Strengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of device safety and oversight that mandate attention.
To review the regulatory history and clinical evidence of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) and use the device recall as a case study of the challenges associated with clinical evaluation, transparency, and oversight of medical devices in the US.
Regulatory history and clinical evidence for the Penumbra medical devices were analyzed through a qualitative review of decision letters in the Access FDA database for medical devices and medical device reports in the Manufacturer and User Facility Device Experience database and a review of market data (eg, earnings calls, company communications) and clinical literature.
The JET 7 device was subjected to a class I recall following more than 200 adverse event reports, 14 of which involved patient deaths. Regulatory analysis indicated that each of the Penumbra reperfusion catheters was cleared under the 510(k) pathway (which allows devices to be authorized with limited to no clinical evidence), with limited submission of either new clinical or animal data. Clinical evidence for Penumbra devices was generated from nonrandomized, single-arm trials with small sample sizes. The regulatory issues raised by JET 7 are reflective of broader challenges for medical device regulation. Opportunities for reform include strengthening premarket evidence requirements, requiring safety reporting with unique device identifiers, and mandating active methods of postmarket surveillance.
Conclusions and Relevance
The case study of JET 7 highlights the long-standing gaps in medical device oversight and renews the impetus to build on the Institute of Medicine recommendations and reform FDA medical device regulation to protect public health.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: September 9, 2021.
Published Online: November 29, 2021. doi:10.1001/jamainternmed.2021.6626
Corresponding Author: Harlan M. Krumholz, MD, SM, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, 195 Church St, 5th Flr, New Haven, CT 06510 (firstname.lastname@example.org).
Author Contributions: Mr Kadakia and Mr Beckman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: Ross.
Drafting of the manuscript: Kadakia, Beckman.
Critical revision of the manuscript for important intellectual content: All authors.
Administrative, technical, or material support: Kadakia, Beckman.
Conflict of Interest Disclosures: Mr Kadakia reported previous employment at Cleveland Clinic London, Blue Cross Blue Shield of North Carolina, and the US Food and Drug Administration (FDA), and has received consulting fees from the National Academy of Medicine, all unrelated to this article. At the time of publication, Mr Beckman is on a leave of absence from Harvard and is serving in the federal government COVID-19 response. However, this article was conceived and drafted while Mr. Beckman was a student at Harvard Medical School and Harvard Business School, and the findings and views in this article do not reflect the official views or policy of the Department of Health and Human Services. Dr Ross reported receiving grants from the FDA, Johnson and Johnson, Medical Devices Innovation Consortium, Association for Healthcare Research and Quality, the National Institutes of Health National Heart, Lung, and Blood Institute, and the Laura and John Arnold Foundation outside the submitted work. In the past 3 years, Dr Krumholz received expenses and/or personal fees from UnitedHealth (consulting), IBM Watson Health (consulting), Element Science (consulting), Aetna (consulting), Facebook (consulting), the Siegfried and Jensen Law Firm (expert testimony on behalf of plaintiffs), Arnold and Porter Law Firm (expert testimony on behalf of Bristol-Myers Squibb), Martin/Baughman Law Firm (expert testimony on behalf of plaintiffs), F-Prime (consulting), and the National Center for Cardiovascular Diseases in Beijing (research collaboration).
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