BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 2001471 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14891
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    October 25, 2009
    Report Date
    January 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: DEVICE REMAINS IMPLANTED. NO REPORT OF AUTOPSY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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. PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED. SEE REPORT FOR SERIAL NUMBER (B)(4). NO CAUSE OF DEATH WAS PROVIDED. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR IF AN AUTOPSY WAS DONE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE HEALTH CARE PROVIDER WHICH INDICATED CAUSE OF DEATH WAS "ENDOCARDITIS, MITRAL ALREADY HAD PROBLEMS BEFORE OPERATION". SURGEON INDICATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. DATE OF DEATH WAS CONFIRMED TO BE (B)(6) 2009 FOR AN IMPLANT DURATION OF 4 MONTHS 11 DAYS (4.37 MONTHS).

    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. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-07F1216

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| R