BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1880728 · Received October 25, 2010

    Report

    Report Number
    2015691-2010-14256
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 27, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: CONCLUSION: AFTER REPEATED ATTEMPTS TO GATHER INFORMATION REGARDING THE REPORTED EVENT, THERE WAS NO FURTHER INFORMATION OBTAINED DURING THE INVESTIGATION PROCESS. THE RELATIONSHIP OF THE DEVICE TO THE ADVERSE EVENT (IN THIS CASE, DEATH) COULD NOT CONCLUSIVELY BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED. THE DEVICE PASSED ALL MANUFACTURING AND INSPECTION SPECIFICATIONS. THERE WERE NO NONCONFORMANCES IDENTIFIED THAT COULD BE RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON VIA A TELEPHONE VOICEMAIL REGARDING A PROBABLE VALVE FAILURE. PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 59.43 MONTHS. PATIENT WAS SYMPTOMATIC WITH SHORTNESS OF BREATH, DIED DUE TO SUDDEN CARDIAC DEATH ON SUNDAY MORNING ((B)(6)2010). THE DECEASED IS IN A FUNERAL HOME. THE PATIENT'S HUSBAND DID NOT REQUEST AN AUTOPSY TO BE PERFORMED AND THE STATE OF (B)(6) WILL NOT PERFORM AN AUTOPSY. THEREFORE THE DEVICE IS UNAVAILABLE FOR RETURN AS IT IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 5H1609

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death