BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1737443 · Received June 25, 2010

    Report

    Report Number
    2015691-2010-13628
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    November 18, 2009
    Report Date
    June 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD OTHER DEVICES IMPLANTED; (B) (4). TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA EMAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. 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 DURING A VASCULAR PROCEDURE, THERE WAS A CUTTING CLIP. THE CLIPS WOULDN'T HOLD ON A SMALL COLLATERAL ARTERY, AS THEY WERE NOT COMPLETELY CLOSED. MOREOVER, ONE OF THE CLIPS CUT THE VESSEL. THE ISSUE CAUSED A BLEEDING IN UNKNOWN QUANTITY BUT NOT REQUIRING A TRANSFUSION, ACCORDING TO OUR CONTACT. THE BLEEDING WAS CONTROLLED WITH COMPRESSES AND FASTIDIOUS MANUAL SUTURES DUE TO THE PROXIMITY OF LINGUAL AND FACIAL NERVES. THE PROCEDURE WAS EXTENDED BY THIRTY MINUTES. DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.07 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION 5 MONTHS AFTER IMPLANT. THE REASON STATED WAS THE PATIENT'S DISSATISFACTION WITH THE HALOS HE WAS EXPERIENCING, CAUSE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX 09J228

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R