BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2080952 · Received May 8, 2011

    Report

    Report Number
    2015691-2011-15488
    Event Type
    Injury
    Date Received
    May 8, 2011
    Date of Event
    September 7, 2010
    Report Date
    February 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SIZING ISSUE. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE OPERATIVE REPORT WAS TRANSLATED ON (B)(6) 2011 WHICH PROVIDED INFORMATION THAT THE PATIENT HAD BEEN TAKEN OFF BYPASS BEFORE THIS DEVICE WAS EXPLANTED. THIS INCREASED THE RISK TO THE PATIENT. HOWEVER, THE SURGEON INDICATED IN HIS INITIAL RESPONSE THAT THIS EXPLANT WAS NOT DEVICE RELATED BUT WAS DUE TO PATIENT RELATED FACTORS AND THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THE DEVICE (23MM) WAS EXPLANTED AT IMPLANT DUE TO SIZING, IT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE. PER TRANSLATION OF THE OPERATIVE REPORT: IMPLANTATION OF FIRST VALVE WITHOUT PROBLEM, BUT IT WAS MENTIONED THAT THE 23 MM VALVE MIGHT BE SLIGHTLY BE TOO BIG, BUT IT WAS PLACED FINE. WHEN REMOVING THE CLAMP FROM THE AORTA, THE FUNCTION OF LEFT VENTRICLE DID NOT RECOVER. EVEN AFTER "REPERFUSION" TIME, THE HEART PUMP FUNCTION DID NOT IMPROVE WITH NORMAL RIGHT VENTRICLE CONTRACTION. IT IS ASSUMED THAT THERE IS A PROBLEM ON THE LEFT MAIN STEM. IT WAS DECIDED TO CLAMP THE AORTA AGAIN. AFTER RE-OPENING THE AORTA, IT WAS SEEN THAT THERE IS NO PROBLEM WITH THE LEFT MAIN STEM OR CORONARY OSTIUM. IT WAS THOUGHT THAT MAYBE THE SLIGHTLY OVERSIZED VALVE CAUSED A COMPRESSION ON THE LEFT MAIN STEM AND IT WAS DECIDED TO REPLACE THE VALVE AND TO IMPROVE THE SITUATION WITH A 21MM VALVE. REMOVING 23MM VALVE AND IMPLANTING 21MM VALVE WITHOUT PROBLEMS. ECHO SHOWS A GOOD BIVENTRICULAR FUNCTION, GOOD POSITION OF THE VALVE AND NO SIGN OF PARAVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 10F136

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R