In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

Oz did not respond to a request for comment on that statement.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

On the presidential campaign trail, former President Donald Trump is, once again, promising to repeal and replace the Affordable Care Act — a nebulous goal that became one of his administration’s splashiest policy failures.

“We’re going to fight for much better health care than Obamacare. Obamacare is a catastrophe,” Trump said at a campaign stop in Iowa on Jan. 6.

The perplexing revival of one of Trump’s most politically damaging crusades comes at a time when the Obama-era health law is even more popular and widely used than it was in 2017, when Trump and congressional Republicans proved unable to pass their own plan to replace it. That failed effort was a big part of why Republicans lost control of the House of Representatives in the 2018 midterms.

Despite repeated promises, Trump never presented his own Obamacare replacement. And much of what Trump’s administration actually accomplished in health care has been reversed by the Biden administration.

Still, Trump secured some significant policy changes that remain in place today, including efforts to bring more transparency to prices charged by hospitals and paid by health insurers.

Trying to predict Trump’s priorities in a second term is even more difficult given that he frequently changes his positions on issues, sometimes multiple times.

The Trump campaign did not respond to a request for comment.

Perhaps Trump’s biggest achievement is something he rarely talks about on the campaign trail. His administration’s “Operation Warp Speed” managed to create, test, and bring to market a covid-19 vaccine in less than a year, far faster than even the most optimistic predictions.

Many of Trump’s supporters, though, don’t support — and some even vehemently oppose — covid vaccines.

Here is a recap of Trump’s health care record:

Public Health

Trump’s pandemic response dominates his overall record on health care.

More than 400,000 Americans died from covid over Trump’s last year in office. His travel bans and other efforts to prevent the global spread of the virus were ineffective, his administration was slower than other countries’ governments to develop a diagnostic test, and he publicly clashed with his own government’s health officials over the response.

Ahead of the 2020 election, Trump resumed large rallies and other public campaign events that many public health experts regarded as reckless in the face of a highly contagious, deadly virus. He personally flouted public health guidance after contracting covid himself and ending up hospitalized.

At the same time, despite what many saw as a politicization of public health by the White House, Trump signed a massive covid relief bill (after first threatening to veto it). He also presided over some of the largest boosts for the National Institutes of Health’s budget since the turn of the century. And the mRNA-based vaccines Operation Warp Speed helped develop were an astounding scientific breakthrough credited with helping save millions of lives while laying the groundwork for future shots to fight other diseases including cancer.

Abortion

Trump’s biggest contribution to abortion policy was indirect: He appointed three Supreme Court justices, who were instrumental in overturning the constitutional right to an abortion.

During his 2024 campaign, Trump has been all over the place on the red-hot issue. Since the Supreme Court overturned Roe v. Wade in 2022, Trump has bemoaned the issue as politically bad for Republicans; criticized one of his rivals, Florida Gov. Ron DeSantis, for signing a six-week abortion ban; and vowed to broker a compromise with “both sides” on abortion, promising that “for the first time in 52 years, you’ll have an issue that we can put behind us.”

He has so far avoided spelling out how he’d do that, or whether he’d support a national abortion ban after any number of weeks.

More recently, however, Trump appears to have mended fences over his criticism of Florida’s six-week ban and more with key abortion opponents, whose support helped him get elected in 2016 — and whom he repaid with a long list of policy changes during his presidency.

Among the anti-abortion actions taken by the Trump administration were a reinstatement of the “Mexico City Policy” that bars giving federal funds to international organizations that support abortion rights; a regulation to bar Planned Parenthood and other organizations that provide abortions from the federal family planning program, Title X; regulatory changes designed to make it easier for health care providers and employers to decline to participate in activities that violate their religious and moral beliefs; and other changes that made it harder for NIH scientists to conduct research using fetal tissue from elective abortions.

All of those policies have since been overturned by the Biden administration.

Health Insurance

Unlike Trump’s policies on reproductive health, many of his administration’s moves related to health insurance still stand.

For example, in 2020, Trump signed into law the No Surprises Act, a bipartisan measure aimed at protecting patients from unexpected medical bills stemming from payment disputes between health care providers and insurers. The bill was included in the $900 billion covid relief package he opposed before signing, though Trump had expressed support for ending surprise medical bills.

His administration also pushed — over the vehement objections of health industry officials — price transparency regulations that require hospitals to post prices and insurers to provide estimated costs for procedures. Those requirements also remain in place, although hospitals in particular have been slow to comply.

Medicaid

While first-time candidate Trump vowed not to cut popular entitlement programs like Medicare, Medicaid, and Social Security, his administration did not stick to that promise. The Affordable Care Act repeal legislation Trump supported in 2017 would have imposed major cuts to Medicaid, and his Department of Health and Human Services later encouraged states to require Medicaid recipients to prove they work in order to receive health insurance.

Drug Prices

One of the issues the Trump administration was most active on was reducing the price of prescription drugs for consumers — a top priority for both Democratic and Republican voters. But many of those proposals were blocked by the courts.

One Trump-era plan that never took effect would have pegged the price of some expensive drugs covered by Medicare to prices in other countries. Another would have required drug companies to include prices in their television advertisements.

A regulation allowing states to import cheaper drugs from Canada did take effect, in November 2020. However, it took until January 2024 for the FDA, under Trump’s successor, to approve the first importation plan, from Florida. Canada has said it won’t allow exports that risk causing drug shortages in that country, leaving unclear whether the policy is workable.

Trump also signed into law measures allowing pharmacists to disclose to patients when the cash price of a drug is lower than the cost using their insurance. Previously pharmacists could be barred from doing so under their contracts with insurers and pharmacy benefit managers.

Veterans’ Health

Trump is credited by some advocates for overhauling Department of Veterans Affairs health care. However, while he did sign a major bill allowing veterans to obtain care outside VA facilities, White House officials also tried to scuttle passage of the spending needed to pay for the initiative.

Medical Freedom

Trump scored a big win for the libertarian wing of the Republican Party when he signed into law the “Right to Try Act,” intended to make it easier for patients with terminal diseases to access drugs or treatments not yet approved by the FDA.

But it is not clear how many patients have managed to obtain treatment using the law because it is aimed at the FDA, which has traditionally granted requests for “compassionate use” of not-yet-approved drugs anyway. The stumbling block, which the law does not address, is getting drug companies to release doses of medicines that are still being tested and may be in short supply.

Trump said in a Jan. 10 Fox News town hall that the law had “saved thousands and thousands” of lives. There’s no evidence for the claim.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.