CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL 6625Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103021936), received between Feb 24, 2021 and May 21, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 6625 PORCINE VALVE , IMPLANTED IN TRICUSPID POSITION, UNDERWENT A VALVE -IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, 10 MONTHS DUE TO TRICUSPID STENOSIS AND REGURGITATION. THE TTVR WAS PERFORMED WITH A 26MM 9750TFX VALVE.

  Patient problems: Insufficient Information

  MAUDE report 11863333 ↗
• InjuryFeb 24, 2021Degraded; Fluid/Blood Leak; Gradient Increase; Degraded; Fluid/Blood Leak; Gradient Increase

  EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH A 25MM 6625 MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS DUE TO DEGENERATION LEADING TO SEVERE MITRAL STENOSIS AND MODERATE MITRAL REGURGITATION. AS REPORTED, THE PATIENT PRESENTED WITH INTERMITTENT ASTHMATIC SUFFOCATION DURING ACTIVITIES, INCAPABILITY TO SUPINE AFTER WAKING UP AT NIGHT, REDUCED ACTIVITY TOLERANCE, COUGH PINK FOAM SPUTUM. AFTER WALKING 200 METERS ASTHMATIC SUFFOCATION SYMPTOMS APPEARED. NO CHEST PAIN, NO DIZZINESS, NO HEADACHE, NO PALPITATIONS, NO PERSPIRATION, NO BLACKNESS OR SYNCOPE. THIS PATIENT WAS A HIGH RISK FOR RE-DO MVR (STS 13.564%) AND FRAILTY (INDUCED BY OPEN CHEST SURGERY AND BLOOD LOSS). A SAPIEN 3 TRANSCATHETER VALVE WAS IMPLANTED IN REPLACEMENT. AFTER IMPLANTING A SAPIEN 3 VALVE WITH A GOOD POSITION AND GRADIENT, IMMEDIATELY THE BLOOD PRESSURE DECREASE AND S-T SEGMENT ELEVATE. ECHO DIAGNOSIS SHOWED PERICARDIAL EFFUSION AND DEVELOPED INTO CARDIAC TAMPONADE. OPEN CHEST SURGERY WAS PERFORMED TO DEAL WITH PERICARDIAL EFFUSION. THE BLOOD WAS STOPPED; VITAL SIGNS WERE STABLE. THE PERICARDIAL EFFUSION WAS INDUCED BY SUPPORT WIRE PERFORATION. AT LAST

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 11373755 ↗