BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2143187 · Received June 28, 2011

    Report

    Report Number
    2015691-2011-15798
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE NOT RETURNED. (B)(4) - PERIVALVULAR LEAK. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IT WAS LEARNED THAT THE EXPLANTED DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION OR QUALITY DEFICIENCY THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    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 AFTER AN IMPLANT DURATION OF APPROXIMATELY 53 MONTHS, AND REPLACED WITH SAME MODEL, SMALLER SIZE (19MM) EDWARDS' VALVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO A PERIVALVULAR LEAK. THE SURGEON INDICATED THAT THE EXPLANT WAS DUE TO PATIENT-PROSTHESIS MISMATCH, AND IS NOT RELATED TO A DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 R-06J0395

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention