Experts: Penumbra recall highlights ‘device creep,’ makes case for regulatory reform

Regulatory NewsRegulatory News | 30 November 2021 |  By 

The recent class I recall of a Penumbra cardiac device used in mechanical thrombectomy procedures provides a case study for the shortcomings of the current 510(k) medical device clearance process and the need for more robust device adverse event reporting and postmarketing surveillance, according to a review published in JAMA Internal Medicine.
Penumbra, a California-based medical device company, recalled its JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) in December 2020, just over a year after it was cleared for marketing by the US Food and Drug Administration (FDA) through the 510(k) process. The class I recall followed more than 200 reports of adverse events, including 14 deaths.
“JET 7 raises several issues ranging from widespread use in patient care despite limited clinical evidence demonstrating safety and effectiveness to gaps in postmarket surveillance. These issues are familiar for medical device regulation in the US, a field which has long faced challenges regarding clinical evaluation, transparency, and oversight,” Harlan M. Krumholz, MD, of the Yale School of Medicine and his coauthors wrote in a Special Communication in JAMA Internal Medicine.
Krumholz and colleagues trace the issues with the JET 7 back to 2007, when the FDA cleared the first Penumbra device – the Penumbra System – just the second mechanical device authorized to treat acute ischemic stroke. The Penumbra System was cleared through the 510(k) process, which allowed it to be authorized based on its “substantial equivalence” to an existing, “predicate” device. The predicate device was the Merci Retriever from Concentric Medical, which was itself cleared based on equivalence to a predicate device. The authors noted that the Penumbra pivotal trial was a single-arm study with 125 participants.
Over the next decade, the FDA cleared 12 Penumbra devices using previous iterations as predicates. A review of FDA decision letters found that just one of the 12 devices had new clinical data supporting its clearance. Six of the letters referenced new animal data and the others referenced only biocompatibility and benchtop studies. In the case of the JET 7, the device was cleared based on the strength of a literature review and preexisting animal data.
“The false sense of security emanating from the overreliance on predicate devices is known as ‘device creep,’ a situation in which purportedly iterative changes in device design contribute to meaningful (and potentially detrimental) changes in device function,” Krumholz and colleagues wrote. “In the case of JET 7, change to catheter design were innocuous in benchtop studies but raised safety concerns in real-world clinical environments.”
Another issue highlighted by JET 7 is the classification of medical devices. JET 7, for instance, was classified as a class II device, which is the same risk category the FDA uses for surgical face masks and powered wheelchairs.
The authors also raised concerns about the current passive safety reporting and postmarketing surveillance systems. They noted that the 200 adverse event reports about JET 7 were likely an underestimate since reporting is voluntary for patient and physicians – who are most likely to notice safety issues – and are often logged months after an incident and with incomplete information, such as missing product numbers. In the case of JET 7, the safety concerns were raised by “activist investors” began publicizing reports about injuries and deaths, the authors reported.
The authors also pointed out the need to strengthen the postmarketing surveillance of medical devices. Currently, the FDA only requires postmarketing studies for a “fraction” of devices authorized through the 510(k) process. Those studies are frequently delayed and in some cases the results are never reported. In contrast, the European Union requires all manufacturers to develop postmarket surveillance plans. In Iceland, regulators have implemented a national postmarket registry for medical devices. Part of the problem in establishing active surveillance registries in the US is a lack of federal funding, the authors explained.
“With negotiations to reauthorize the Medical Device User Fee Amendments currently under way, lawmakers should consider broadening industry user fees – which are primarily used to fund premarket review activities – to apply to postmarket surveillance activities, including funding for independent groups to organize registries,” Krumholz and colleagues wrote.
In an accompanying editorial, Rita F. Redberg, MD, editor of JAMA Internal Medicine and colleagues at the University of California, San Francisco, wrote that the failure of premarket review of the Penumbra device highlights the need to improve regulation of medical devices in the US. They noted that the majority of medical devices are approved through the 510(k) pathway and most high-risk recalls are for devices cleared through the 510(k) pathway.
“Many deaths could be avoided with better reporting of adverse events and routine surveillance by the FDA of these reports,” Redberg and colleagues wrote. “To identify patient harms from medical devices earlier, Congress should provide the agency with the resources it needs to develop robust and prospective surveillance systems.”
JAMA Internal Medicine Special Communication


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