BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2001496 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14902
    Event Type
    Death
    Date Received
    February 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. CAUSE OF DEATH HAS NOT BEEN PROVIDED. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR IF AN AUTOPSY WAS DONE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. ON (B)(6) 2011, A RESPONSE WAS RECEIVED WHICH INDICATED THAT THE CAUSE OF DEATH WAS DUE TO HEMORAGIC/RESPIRATORY SHOCK. THE RESPONSE ALSO NOTES 'SCLERODERMA' (BEFORE OPERATION) AS AN ADDED CAUSE OF DEATH. HOWEVER, THE RESPONSE DOES INDICATE THAT THE SURGEON DISASSOCIATED THE DEVICE FROM THE EVENT. OPERATIVE REPORT AND/OR DISCHARGE SUMMARY WERE REQUESTED BUT WILL NOT BE PROVIDED. DEVICE WAS NOT EXPLANTED AND NO AUTOPSY WAS NOTED; THEREFORE, THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE HEALTH CARE PROVIDER INDICATING THAT THE PATIENT DIED ON (B)(6) 2010 GIVING AN IMPLANT DURATON OF 28 DAYS (0.93 MONTHS) DUE TO HEMORAGIC/RESPIRATORY SHOCK. THE RESPONSE NOTES 'SCLERODERMA' (BEFORE OPERATION) AS AN ADDED CAUSE OF DEATH.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, THE PATIENT EXPIRED. THE DATE OF PATIENTS' DEATH AND IMPLANT DURATION ARE UNKNOWN. CAUSE OF DEATH HAS NOT BEEN PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 09B041

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death