CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC 2650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103146899), received between Dec 3, 2021 and Dec 3, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2021Degraded; Gradient Increase; Degraded; Gradient Increase

  EDWARDS RECEIVED NOTIFICATION THAT THIS 70-Y-O PATIENT WITH A PORCINE SAV VALVE MODEL 265025MM IMPLANTED IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS AND 8 MONTHS DUE TO DEGENERATION LEADING TO STENOSIS. AS REPORTED, ECHO PRIOR TO VALVE IN VALVE TAVI EF 60-65. EF 61, STENOSIS OF PROSTHETIC AV 78/48, DVI .27, AVA 1.03CM2. THE PATIENT PRESENTED WITH WORSENING HEART FAILURE WHICH PROMPTED REINTERVENTION. A 26MM SAPIEN3 ULTRA VALVE WAS IMPLANTED WITHIN THE SURGICAL EDWARDS VALVE USING THE TRANSFEMORAL APPROACH. ECHO POST PA PRESSURES WERE NORMAL WITH NORMAL FUNCTIONING OF THE AORTIC VALVE PROSTHESIS. WELL FUNCTIONING TAVI VALVE. PEAK 26, MEAN 13. THE PATIENT WAS NOTED AS DISCHARGED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 12929345 ↗