BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 1953333 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14643
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    October 15, 2010
    Report Date
    December 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 2800, WHICH IS MARKETED WITHIN THE UNITED STATES. 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. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL. THE (B)(4) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED INCLUDING THE EXPLANT SURGEON, OPERATIVE REPORT, AND ADDITIONAL PATIENT HISTORY. THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AND REPLACE A VALVE, THE MOST COMMON OF WHICH IS REGURGITATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, AND PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. IN THIS CASE, THE CUSTOMER HAS NOT PROVIDED A REASON FOR THE EXPLANT AND REPLACEMENT OF THIS DEVICE, AND THERE IS NO ADDITIONAL INFORMATION FORTHCOMING. FOR THESE REASONS, WE ARE UNABLE TO PROVIDE A ROOT CAUSE FOR THE EXPLANT OF THIS DEVICE.

    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 DEVICE WAS EXPLANTED AFTER 2 YEARS 11 MONTHS (35 MONTHS) DUE TO UNKNOWN REASONS AND WAS REPLACE BY A CARPENTIER-EDWARDS 3000-21MM VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 07H204

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R