BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3930209 · Received July 11, 2014

    Report

    Report Number
    2015691-2014-01574
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 13, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE EXPLANT OR THE PATIENT'S DEATH. THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED AT THIS TIME. THERE IS NO INFORMATION TO SUGGEST A RELATIONSHIP BETWEEN THE EDWARDS DEVICE AND THE PATIENT'S DEATH. ADDITIONAL INFORMATION WILL BE REPORTED IF RECEIVED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    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, EDWARDS RECEIVED INFORMATION THAT A SIZE 21 BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY SIX (6) MONTHS AND TWENTY-SIX (26) DAYS AGO, WAS EXPLANTED AND REPLACED WITH ANOTHER EDWARDS SAME MODEL VALVE, BUT SIZE 19. A PHONE CALL FROM THE PATIENT'S WIFE INDICATES THAT THE PATIENT PASSED ON SURGERY DAY DUE TO CARDIAC ARREST. EDWARDS IS PERFORMING FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406476 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX S-13E1944

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R