BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2073487 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15402
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    December 24, 2010
    Report Date
    April 1, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE SURGEON'S RESPONSE INDICATED THAT THE DEVICE EXPLANT WAS DUE TO A SIZING ERROR AND NOT A DEVICE MALFUNCTION. BECAUSE THE EXPLANT HAD NOTHING TO DO WITH THE VALVE, THE HOSPITAL DID NOT HOLD ON TO THE DEVICE AND IT WAS DISCARDED. THEREFORE, IT IS NOT AVAILABLE FOR RETURN AND EVALUATION THE OPERATIVE REPORT WAS REQUESTED BUT WILL NOT BE PROVIDED. NO ADDITIONAL INFORMATION IS FORTHCOMING FROM THE HEALTH CARE PROVIDER. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: WHEN A VALVE IS REPORTED AS EXPLANTED AT IMPLANT DUE TO A SIZING ERROR, IT IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING OR AN ISSUE WITH PATIENT ANATOMY AND NOT THE RESULT OF A MALFUNCTION OF THE DEVICE. IF IT REQUIRES REINSTITUTION OF CARDIOPULMONARY BYPASS (CPB) TO EXPLANT THE DEVICE, THIS MAY REQUIRE SIGNIFICANTLY EXTENDED OPERATIVE AND CPB TIME, WHICH INCREASES THE RISK OF THE PROCEDURE. IN THIS CASE, THE SURGEON DID NOT INDICATE IF THE PATIENT HAD BEEN TAKEN OFF CPB PRIOR TO EXPLANT AND REPLACEMENT OF THE DEVICE. HOWEVER, NO ADDITIONAL INFORMATION IS FORTHCOMING FROM THE HEALTH CARE PROVIDER. WITHOUT THE OPERATIVE REPORT, WE CANNOT INVESTIGATE FURTHER INTO THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    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, THE 27MM VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH A 25MM VALVE DUE TO A SIZING ERROR. THE SURGEON INDICATED IN HIS RESPONSE THAT THIS EXPLANT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE.

    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 S-10J2626

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R