Dive Brief:
- Boston Scientific has contacted customers about problems with defibrillation leads associated with more than 10 deaths.
- The Food and Drug Administration, which published an early alert about the issue Wednesday, said there have been reports of 386 serious injuries and 16 deaths. However, Boston Scientific said in a statement to MedTech Dive that two of the deaths were later found to be unrelated to the issue.
- Calcification of the lead coils may have made the defibrillation devices less effective. Boston Scientific said devices susceptible to the phenomenon are no longer available commercially.
Dive Insight:
The problem affects certain Endotak Reliance defibrillation leads with expanded polytetrafluoroethylene-coated coils. Calcification can biologically encapsulate and electrically insulate the defibrillation lead coil. This may reduce the efficacy of shocks and can necessitate the early removal of the device.
A Boston Scientific spokesperson said a review of post-market data revealed 10 deaths associated with a pattern of gradual impedance rise and unsuccessful termination of a sustained ventricular arrhythmia. The review identified a further four deaths associated with extraction for devices exhibiting a gradually rising electrical impedance.
“Direct causation between these deaths and this calcification phenomenon cannot be assumed nor confirmed,” the spokesperson said. “While the FDA references 16 deaths, two of those, initially reported, were later adjudicated and found to not be associated with this phenomenon.”
Boston Scientific wrote to healthcare providers about the reports last month. The company has advised physicians to continue routine follow-up of patients with the leads. The spokesperson said a gradual rise in impedance is highly detectable through normal follow-up appointments, adding that leads may be implanted for up to eight years before the changes are seen.
Boston Scientific has shared recommendations for detecting early signs of calcification. Physicians who are planning to replace leads should consider risks and benefits of lead extraction versus abandonment, the company said. Boston Scientific told physicians that, based on implant time and likely coil calcification, the leads may pose an increased risk of extraction-related complications.
The recall affects around 354,000 active ePTFE-coated single-coil and dual-coil Reliance defibrillation leads globally, the spokesperson said. Boston Scientific manufactured the leads between 2002 and 2021.
