BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2132967 · Received June 17, 2011

    Report

    Report Number
    2015691-2011-15739
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS RELATED TO THIS DEVICE WAS COMPLETED AND THE RESULTS DEMONSTRATE THAT THE DEVICE MET ALL SPECIFICATIONS. CONCLUSION: THERE ARE SEVERAL REASONS WHY A VALVE IS EXPLANTED AT IMPLANT. THIS IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE SURGEON HAS INDICATED THAT THE EXPLANT OF THIS DEVICE WAS DUE TO A SIZING ISSUE BUT GIVES NO FURTHER INFORMATION. WITHOUT THE ADDITIONAL EVENT INFORMATION OR RETURN OF THE DEVICE FOR EVALUATION, WE ARE UNABLE TO DETERMINE 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, A 25MM VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH A 23MM VALVE DUE TO REGURGITATION. PER THE RESPONSE RECEIVED FROM THE HEALTH CARE PROVIDER, IT WAS INDICATED THAT THE VALVE SIZE 25MM WAS EXPLANTED AT IMPLANT DUE TO REGURGITATION AS A RESULT OF A SIZING ISSUE AND 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 PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX 10A010

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R