BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1984306 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14770
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    July 19, 2010
    Report Date
    January 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NOTIFICATION OF THE DEATH WAS PROVIDED BY THE FAMILY. NO CAUSE OF DEATH WAS PROVIDED. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR IF AN AUTOPSY HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN LEARNED THOUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THIS EVENT WAS REPORTED IN ERROR.

    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 AFTER AN IMPLANT DURATION OF 28 DAYS (0.93 MONTHS). NO CAUSE OF DEATH HAS BEEN PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED IN ERROR. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER IT WAS LEARNED THAT ALTHOUGH THE PATIENT EXPIRED 28 DAYS (0.93 MONTHS) AFTER SURGERY, THE EDWARD'S VALVE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    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 10A010

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R