BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2183353 · Received July 28, 2011

    Report

    Report Number
    2015691-2011-15965
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 30, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. MULTIPLE ATTEMPTS TO OBTAIN OPERATIVE REPORT AND SUBJECT DEVICE FOR RETURN WERE UNSUCCESSFUL. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION RELATED 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' MITRAL VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH ANOTHER EDWARDS' VALVE. THROUGH FOLLOW-UP, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO ATRIOVENTRICULAR DEHISCENCE (AV DEHISCENCE). THE HEALTHCARE PROVIDER INDICATED THAT THE REASON FOR EXPLANT IS PROCEDURE AND PATIENT RELATED AND NOT DUE 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 MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-11B0701

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R