Recalled leads illustrate fissures in FDA process

Citing two cases involving recalled leads in implantable cardiac devices as examples, two California researchers called for more postmarketing surveillance, publicly available data registries and better labeling to help physicians assess devices’ risks and benefits.

Writing online March 25 in the Annals of Internal Medicine, Sarah Y. Zheng, AB, and Rita F. Redberg, MD, of the University of California, San Francisco, outlined changes they recommended be made to cover gaps in the FDA’s process.

Class III devices that are defined as life-supporting receive premarket approval (PMA), with iterations that follow cleared in a PMA supplement process. That allows for rapid distribution of the modified devices but also may introduce unknown risk to patients, they argued. They highlighted the cases of two different defibrillator leads as examples of devices that had gone through multiple iterations and eventually were recalled for safety reasons. The leads were the Sprint Fidelis (Medtronic) and Riata (St. Jude Medical).

The authors wrote that these products, although now recalled, had been implanted in hundreds of thousands of patients, posing an ongoing clinical challenge for cardiologists and other physicians.

“Because the PMA supplement process is piecemeal, the accumulation of supplements may result in a final product that differs significantly from the original device,” they wrote. “Clinicians are generally unaware that the device they are considering for their patients has been modified (and often not tested) since they read about the original unmodified device in published clinical trials.”   

They added that several models of a product may be on the market simultaneously, making it more difficult for physicians to keep pace with changes that aren’t necessarily obvious in labeling. They wrote that the need for expediency must be balanced with patient safety, “particularly because many implanted PMA devices cannot be easily removed after a recall.”

In addition to FDA’s Unique Device Identification program, they recommended robust postmarket surveillance systems to collect and analyze product data, publicly accessible data registries with clinical outcomes and adverse events and more direct labeling on devices. “These improvements would allow physicians to help patients make better informed decisions by more accurately reflecting risks and benefits.”