BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 1897171 · Received November 12, 2010

    Report

    Report Number
    2015691-2010-14363
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 6625, WHICH IS MARKETED WITHIN THE UNITED STATES. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: REASON FOR PROCEDURE IS UNKNOWN. BOTH DEVICES REMAIN IMPLANTED. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: RESPONSE FROM THE HEALTH CARE PROVIDER INDICATED THAT "WE PERFORMED A VALVE-IN-VALVE. THE REASON WAS DUE TO A "LEAFLET RUPTURE DETECTED BY TEE". THE TEE WAS NOT RECEIVED ON DVD. HOWEVER, 1 AVI FILE WAS RECEIVED AND CANNOT BE USED FOR IMPRESSION. DUE TO THE VALVE-IN-VALVE PROCEDURE, THE DEVICE CANNOT BE RETURNED AS IT REMAINS IMPLANTED. THE OPERATIVE REPORT WAS PROVIDED, BUT IS NOT IN ENGLISH AND HAS NOT BEEN TRANSLATED. NO ADDITIONAL PATIENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" 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, A SECOND DEVICE WAS IMPLANTED IN THE SAME POSITION USING A VALVE-IN-VALVE PROCEDURE. DURATION OF IMPLANT OF THE INITIAL DEVICE AT THE TIME OF THE PROCEDURE WAS APPROXIMATELY 9 YEARS (110.90 MONTHS).

    Description of Event or Problem · 1

    ON 11/15/2010, A RESPONSE WAS RECEIVED FROM THE HEALTH-CARE PROVIDER STATING THE VALVE-IN-VALVE PROCEDURE WAS PERFORMED DUE TO A LEAFLET RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 00J011

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R