BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1984067 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14766
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    October 9, 2010
    Report Date
    January 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IT HAS BEEN LEARNED THROUGH 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.

    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. ON 01/31/2011, THE PERMANENT IDENTIFICATION CARD WAS RECEIVED FROM THE EXECUTOR OF THE PATIENT'S ESTATE WITH THE NOTATION "... DIED OF HEART FAILURE ON (B)(6) 2010." NO ADDITIONAL INFORMATION WAS PROVIDED. DESPITE ATTEMPTS TO CONTACT THE SURGEON BY EMAIL, NO RESPONSE HAS BEEN RECEIVED TO DATE. A REQUEST HAS BEEN MADE TO CONFIRM CAUSE OF DEATH OR TO GET ADDITIONAL INFORMATION REGARDING THIS EVENT BUT HAS NOT BEEN RECEIVED. AT THIS TIME, IT IS UNKNOWN WHERE THE DEATH OCCURRED. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED. CAUSE OF DEATH HAS NOT BEEN CONFIRMED AND IT IS UNKNOWN IF THERE WAS AN AUTOPSY. DEATH CERTIFICATE HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    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 AFTER IMPLANT DURATION OF 11 MONTHS 6 DAYS (11.20 MONTHS), THE EDWARD'S VALVE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S 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 AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 MONTHS (11.20 MONTHS) DUE TO UNKNOWN REASONS. 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 09J237

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| S