BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1459393 · Received September 1, 2009

    Report

    Report Number
    2015691-2009-11451
    Event Type
    Death
    Date Received
    September 1, 2009
    Date of Event
    February 13, 2009
    Report Date
    August 3, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. PATIENT ALSO HAD ANOTHER VALVE IMPLANTED. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    IN 2009 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE CAUSE OF DEATH WAS G.I. BLEEDING MOSF. HOWEVER, IT WAS LEARNED THAT THE EVENT WAS NOT DEVICE RELATED. THE DEVICE HAS BEEN DISASSOCIATED FROM THE EVENT BY THE SURGEON; THEREFORE, IT HAS BEEN DETERMINED THAT THIS EVENT IS NO LONGER REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT GENERATED A POSITIVE RESULT OF 6 IU/ML ON THE AXSYM TOXO IGG ASSAY. THIS PATIENT HAD PREVIOUSLY TESTED NEGATIVE AND THE SAMPLE WAS REPEATED YIELDING A NEGATIVE RESULT OF 0 IU/ML. THE PREVIOUS SAMPLE WAS ALSO RETESTED AND GENERATED A NEGATIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF APPROXIMATELY 0.03 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

    INFO RECEIVED, INDICATES THE HI/LOW FUNCTION IS DRIFTING DOWN.

    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-07L2141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death