BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2921119 · Received January 17, 2013

    Report

    Report Number
    2015691-2013-19131
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 19, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 REPORTED THAT THE VALVE WAS EXPLANTED AT IMPLANT. THE IMPLANTATION DATA CARD WAS RECEIVED WITH THE NOTATION "IMPLANTED, EXPLANTED; REMOVED, OUT." UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. BASED ON THE FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS PRIOR TO DEVICE REMOVAL. THE HEALTH-CARE PROVIDER ALSO ADDED THAT THERE WAS NO MALFUNCTION OR QUALITY DEFICIENCY RELATED TO THE DEVICE. NO OTHER DETAILS REPORTED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26076 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention