| TGA Action ID |
RC-2025-RN-00646-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
RELIANCE ePTFE (GORE) defibrillation leads
Multiple model and serial numbers
Cancelled ARTG's: 217432, 217434 & 217435 |
| ARTG Number |
217432, 217434, 217435 |
| Action Type |
Product Alert |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
RELIANCE ePTFE (GORE) defibrillation leads have an increased potential to exhibit a pattern of gradual rise in LVSI which is associated with calcification of the shocking coil(s).
This calcification phenomenon can biologically encapsulate and electrically insulate the defibrillation lead coil(s).
BSC has completed a comprehensive investigation of ePTFE RELIANCE lead performance to identify the early signs of this phenomenon, characterise its potential effect on shock efficacy, and provide recommendations to mitigate the associated risk.
The most common harm is early lead replacement (1 in 238 at 10yrs). The most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance (1 in 47,500 at 10yrs). |
| Instructions for Customers/Users |
Customer Recommendations:
- Continue routine follow-up of defibrillation systems with ePTFE leads either via in-person or remote monitoring (RM).
- If lead replacement is planned, carefully consider the risk/benefit of lead extraction versus abandonment. Based on implant time and likely coil calcification, these leads may pose an increased risk of extraction-related complications.
- Before deciding to replace a lead, it's recommended to contact Boston Scientific Technical Services.
- Follow the guidance for mitigating risk by assessing 28-day average LVSI and Code-1005 alerts of defibrillation systems with ePTFE leads.
- Distribute the Customer Letter to all healthcare professionals (HCPs) who need to be informed and include it in the patient’s medical record. |
| Action Commencement Date |
29/07/2025 |
| Responsible Entity |
|
| Contact Information |
aptechservice@bsci.com - BSC Technical Services |