BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1659175 · Received April 14, 2010

    Report

    Report Number
    2015691-2010-13119
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY ZERO DAYS. ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. PER THE OPERATIVE REPORT OF (B) (6) 2010, THE PATIENT WENT IN FOR AVR DUE CONGESTIVE HEART FAILURE DUE TO AORTIC STENOSIS AND INSUFFICIENCY. "THE VALVE WAS BROUGHT TO THE FIELD. THE SUTURES WERE PLACED THROUGH THE SEWING RING. THE VALVE WAS THEN SEATED. SUTURES WERE TIED DOWN. THE AORTOTOMY WAS THEN CLOSED WITH RUNNING 4-0 PROLENE SUTURE. THE HEART WAS THEN DEAIRED. INITIALLY THERE WAS NO BLEEDING FROM THAT SITE; HOWEVER, AS REWARMING AND DEAIRING OCCURRED, THERE WAS MORE BLEEDING. MORE PLEDGETED SUTURES WERE PLACED ALONG THIS AREA. THE PATIENT WAS THEN WEANED OFF CARDIOPULMONARY BYPASS. MORE BLEEDING OCCURRED. IT WAS, THEREFORE, DECIDED TO CALL THE PATIENT EXPIRED. AFTER REMOVING THE CANNULAS, THE CHEST WAS THEN CLOSED WITH WIRES AND STAPLES AND LEFT THE OPERATING ROOM EXPIRED."

    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-09K2367

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death