BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2073398 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15389
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DISRUPTION OF THE ATRIOVENTRICULAR JUNCTION. EVALUATION METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS NOT DUE TO THE EDWARDS' DEVICE MALFUNCTION. DESPITE MULTIPLE ATTEMPTS, THE SUBJECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THIS REPORT.

    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 DEVICE WAS EXPLANTED AT IMPLANT DUE TO SIGNIFICANT BLEEDING NOTICED AFTER PLACING THE VALVE. UPON INSPECTION, THERE WAS A DISRUPTION OF THE ATRIOVENTRICULAR JUNCTION AND THEREFORE CARDIOPULMONARY BYPASS WAS REINSTITUTED. THE VALVE WAS REMOVED AND REPLACED. THE SURGEON INDICATES NO MALFUNCTION WITH THE EDWARDS' DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P R-10H2258

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention