BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1664220 · Received April 21, 2010

    Report

    Report Number
    2015691-2010-13180
    Event Type
    Death
    Date Received
    April 21, 2010
    Report Date
    March 22, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THE CAUSE OF DEATH REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE DURING PREPARATION WHILE THE PHYSICIAN REMOVED THE GUIDEWIRE FROM THE CARRIER TUBE HE NOTED THAT THE GUIDEWIRE WAS BROKEN IN TWO PIECES AT THE PROXIMAL END. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME TYPE OF THE DEVICE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT WHO WAS REPORTEDLY IN A GOOD CONDITION.

    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-09M2795

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death