How Medtronic’s billion-dollar HeartWare device went bust

StarTribune – July 9, 2022 – By Burl Gilyard

The company spent five years developing updates that were never completed, derailed by FDA recalls and life-threatening manufacturing defects.

Five years after Medtronic’s billion-dollar purchase of HeartWare International, the company discontinued the device at the center of acquisition — a miniaturized, implantable heart pump — with no clear plans for ever selling it again.

Despite pulling it from the market one year ago, Medtronic is still dealing with the fallout from the device’s shortcomings, including lawsuits, ongoing regulatory recalls and media investigations.

The HeartWare Ventricular Assist Device (HVAD) was designed for patients battling severe heart failure. Once the market leader, HVAD is now associated with a number of life-threatening manufacturing defects that resulted in serious adverse patient events, including at least 14 deaths.

Several medical technology experts said it was surprising HeartWare remained on the market as long as it did.

“I think the question [at the time] was, ‘Why hasn’t it been pulled from the market yet?'” said Madris Kinard, CEO of Pennsylvania-Based Device Events. “When it happened we were thinking, ‘Of course. This needed to happen.'”

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Signals Newsletter – July 2022 – Ventilators (CPAP & BiPAP)

DEVICE DETAILS
PRODUCT CODES – DESCRIPTION                                                   
BZD                         Ventilator, Non-Continuous (Respirator)
MNS                        Ventilator, Continuous, Non-Life-Supporting

REPORTS RECEIVED BY THE FDA                                                   

View Signals Newsletter – July 2022 – Ventilators (CPAP & BiPAP)

FDA can’t explain drop in device recalls, but experts point to COVID disruptions

Medical Design & Outsourcing – July 6, 2022 – By Danielle Kirsh 

The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.

Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.

Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.

Making the difficult call

Some devices may have stayed on the market longer than they should have due to a fear of shortages in healthcare facilities during the pandemic, said Madris Kinard, the founder and CEO of Device Events and a former unique device identification (UDI) external program manager and adverse events SME for medical devices at the FDA.

“The companies are making these decisions, and then the FDA might review them, but isn’t necessarily taking an active enough approach,” Kinard said.

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‘Where’s the patient?’: Experts question FDA’s final recall guidance

MEDTECHDIVE – April 6, 2022 – By Ricky Zipp

While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.

Medical device recalls and product safety issues have gained public attention over the last several years.

Patients, in particular, have questioned the recall process and criticized the FDA and industry after high-profile events highlighted inefficiencies in the system that put patient safety at risk.

Madris Kinard, CEO of Device Events, a company that compiles and interprets FDA medical device reports and recalls, also thought the inclusion of electronic communications was needed but added that the agency still did not go far enough to address the issue.  “I felt [the guidance] was not written strongly enough,” Kinard said, “because there are serious deficiencies with the recall processes, and moving to all electronic notifications is critical and long, long past due, and that wasn’t mandated or even encouraged as strongly as it needed to be.”

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Millions reported problems with dental implants

YouTube Video – November 9, 2021 – azfamily powered by 3TV & CBS5AZ 

Arizona’s Family Investigates looked into the costly procedure of getting dental implants and why millions of reported problems went unnoticed.

Madris Kinard, CEO and Founder of Device Events, is interviewed at 2:32 of the video.  The Device Events software was used to search the FDA’s MAUDE database and to provide metrics on medical device adverse event reports for this investigation.

Watch The Video…

FDA says Philips knew about toxic foam for years before massive recall

Medical Design & Outsourcing – November 16, 2021 – By Jim Hammerand 

The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.

The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips.

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Signals Newsletter – October 2021 – Staples & Staplers

DEVICE SPOTLIGHT

PRODUCT CODES – DESCRIPTION                                                   
GAG                           Stapler, Surgical
GDW                          Staple, Implantable

REPORTS* RECEIVED BY THE FDA                                                    


 

 

 

 

 

* Includes both Medical Device Reports (MDRs) and Alternative Summary Reports (ASRs)

View Signals Newsletter – August 2021 – Staples & Staplers

FDA medical device regs, safety checks questioned by AMA ethics journal

MEDTECHDIVE – September 29, 2021 – Nick Paul Taylor

The AMA Journal of Ethics has taken a deep dive into U.S. regulation of medical devices, raising questions about whether FDA is striking the right balance between supporting innovation and protecting patients.

In setting up the issue, Ariel Wampler, a plastic and reconstructive surgery physician at Lahey Hospital and Medical Center in Massachusetts, shared data on the regulation, use of and impact of medical devices. Most of the statistics date back years but still provide a snapshot of the case against the current approach. Wampler notes that less than 1% of medical devices went through two large clinical trials, as is standard for pharmaceuticals, from 2003 to 2007.

As it’s typically easier and safer to discontinue use of a drug than an implant, Wampler suggests it “might be reasonable” to expect some devices be held to higher safety standards than pharmaceuticals.

Reported serious safety problems are exceedingly rare — less than 1% of devices cleared or approved between 2004 and 2009 have been subject to a Class I recall, though the recall system itself has also been criticized as being piecemeal and not comprehensive. Clinical trials of implants can be more complex, expensive and ethically problematic than studies of drugs.

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Is the FDA Failing Women?

AMA Journal of Ethics – Viewpoint – September 2021 – Madris Kinard, MBA and Rita F. Redberg, MD, MSc

Abstract

Many devices in current use were marketed before the US Food and Drug Administration (FDA) began regulating devices in 1976. Thus, manufacturers of these devices were not required to demonstrate safety and effectiveness, which presents both clinical and ethical problem for patients, especially for women, as some of the most dangerous devices—such as implanted contraceptive devices— are used only in women. This article investigates whether and to what extent devices for women receive less rigorous scrutiny than devices for men. This article also suggests how the FDA Center for Devices and Radiological Health could more effectively ensure safety and effectiveness of devices that were marketed prior to 1976.

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