BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 1912105 · Received December 1, 2010

    Report

    Report Number
    2015691-2010-14458
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    February 15, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED THIS DEVICE IS NOT DISTRIBUTED OR MARKETED IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. NOTIFICATION WAS RECEIVED IN THE FORM OF A RETURNED PATIENT REGISTRATION CARD WITH THE NOTATION "PT DECEASED ON (B)(6) 2010". NO CAUSE OF DEATH WAS NOTED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. 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. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: 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

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTER" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE REGISTRY WAS INFORMED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF ZERO DAYS. NO CAUSE OF DEATH WAS PROVIDED. THERE WAS NO INDICATION GIVEN THAT THE DEATH WAS DUE TO A DEVICE MALFUNCTION OR THAT THE DEVICE WAS THE CAUSE OF DEATH.

    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 THE DAY OF 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 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 09K268

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R