BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4130895 · Received September 30, 2014

    Report

    Report Number
    2015691-2014-02284
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, THE OPERATIVE REPORT WAS PROVIDED. THE OPERATIVE REPORT STATES "WHILE FIXING THE PARAVALVULAR LEAK, A SMALL DAMAGE WAS CAUSED TO THE LEAFLET OF THE BYPASS SETTING VALVE THAT NECESSITATED TOTAL REPLACEMENT OF THE VALVE." THE SURGEON ALSO INDICATED THIS EXPLANT WAS NOT DUE TO A MALFUNCTION OR QUALITY DEFICIENCY OF THE DEVICE. UNFORTUNATELY, THIS DEVICE IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE HOSPITAL. THE DETAILS OF THE OPERATIVE INTERVENTION: "AFTER A VERY THOROUGH INTERROGATION OF THE VALVE SEATING, WE ACTUALLY FOUND THAT PARAVALVULAR LEAK WAS COMING FROM A DEFECT BELOW THE ANNULUS AT THE LEVEL OF THE JUNCTION OF THE LEFT AND THE NON-CORONARY LEAFLETS OF THE NEW IMPLANTED AORTIC VALVE. 2 ETHIBOND PLEDGETED STITCHES WERE BROUGHT INTO THE FIELD AND THEY WERE PASSED FROM THE ANNULUS OF THE AORTIC VALVE INTO THE SEWING RING OF NEW AORTIC VALVE TO CONTROL THE AREA OF PARAVALVULAR LEAK. DURING THE PLACEMENT PROCESS OF THE STITCHES, 1 OF THE NEEDLES WENT INTO THE LEAFLET ITSELF CAUSING A SMALL TEAR IN THE LEAFLET. DUE TO THE FACT THAT THE TISSUE IS VERY FRAGILE AND IT'S NON-VIABLE ANIMAL TISSUE, WE DID NOT EXPECT IT TO UNDERGO ANY SUBSTANTIAL DEGREE OF HEALING AND WE WERE CONCERNED THAT THIS MIGHT ENHANCE THE FUNCTIONAL DEGENERATION AND THE STRUCTURAL DEGENERATION OF THE VALVE. AT THIS POINT IN TIME, WE FELT THAT THE PATIENT'S BEST INTEREST LIED IN RE-REPLACEMENT OF THE VALVE. THE STITCHES AND THE PLEDGETS WERE TAKEN OUT METICULOUSLY AND THE VALVE WAS REMOVED FROM THE FIELD." THE NEW VALVE WAS IMPLANTED WITHOUT ISSUE. PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS. THE NEW VALVE APPEARED TO BE SEATED IN A VERY GOOD POSITION.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED 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, IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 3300TFX 27MM AORTIC VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH THE SAME MODEL AND SIZE DEVICE. THROUGH FOLLOW UP WITH THE SURGEON, IT WAS LEARNED THE VALVE LEAFLETS HAD BEEN DAMAGED DURING THE IMPLANT PROCESS AND WAS NOT DETECTED UNTIL AFTER THE PATIENT HAD BEEN TAKEN OFF BYPASS. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607451 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R