St. Jude Medical has acknowledged that one of its Durata defibrillator lead wires suffered from “externalized abrasion,” but denies that the model suffers from the same type of critical flaw that forced it to pull its Riata lead wires from the market. According to St. Jude, the externalized abrasion seen with one Durata wire is different than the inside-out abrasion seen in some Riata leads.
Lead wires like the Durata are designed to connect an implanted cardiac defibrillator to the heart and deliver life-saving jolts that either keep a heart beating or regulate the heart rhythm. As we reported earlier this month, a physician anonymously reported the failure of a Durata lead to the U.S. Food & Drug Administration (FDA) back in April. The failure was never reported to St. Jude, which only learned of it when it was posted on the agency’s website.
According to a report from Dow Jones Newswires, St. Jude is now stating that the Durata lead in question was explanted at a Florida hospital, and that the facility has provided the company with static and dynamic fluoroscopy and photographs of the extracted lead. The FDA has confirmed that the serial number on the lead from the Florida hospital matches the one in the report made to the agency.
St. Jude said the damage seen with the Durata lead is consistent with external abrasion from contact with a hardened heart valve or possibly from lead-to-lead contact. According to Dow Jones, St. Jude said it found that the patient had an additional defibrillation lead that had been capped and was no longer being used. Fluoroscopic images showed that the two leads crossed in the region mentioned in the report that was submitted to the FDA. The company maintains that the two wires rubbing together could have resulted in the Durata lead’s failure.
The Durata lead wire was introduced by St. Jude as a replacement for its controversial Riata leads, which the company stopped selling in December 2010, and recalled a year later. An inferior housing on the Riata lead was eventually blamed for the large number of reported failures. A new silicone material known as Optim was used with the Durata lead, St. Jude’s replacement for the Riata.
A St. Jude spokesperson told Bloomberg News that there have been no reports of an inside-out externalized Durata wire.