BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2120882 · Received June 11, 2011

    Report

    Report Number
    2015691-2011-15705
    Event Type
    Injury
    Date Received
    June 11, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. AS THERE IS NO INDICATION OF A DEVICE MALFUNCTION RELATED TO THIS EXPLANT, AND NO DEVICE AVAILABLE FOR RETURN, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. IT WAS INDICATED THAT AFTER THE VALVE WAS PLACED AND THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS, IT WAS NOTED THAT THERE WAS A SMALL SHUNT STILL PRESENT IN THE AREA OF A PATCH REPAIR. IT WAS FELT THAT THIS NEEDED TO BE REPAIRED. THE VALVE WAS REMOVED, THE LEAK REPAIRED, AND ANOTHER EDWARDS VALVE WAS PLACED.

    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 LEARNED THAT THE EDWARDS' VALVE WAS EXPLANTED AT IMPLANT. UPON FOLLOW-UP, THE SURGEON INDICATED THAT THE VALVE WAS EXPLANTED IN ORDER TO ACHIEVE EXPOSURE OF LEAKING VSD PATCH. THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS NOT RELATED TO A DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-10F1575

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R