BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1821295 · Received August 26, 2010

    Report

    Report Number
    2017233-2010-00381
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 26, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE AN ADDITIONAL DEVICES IMPLANTED AND RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, IMAGES SHOWED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN BALLOONED THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT AND NO ENDOLEAK WAS REPORTED. DURING THE FINAL ANGIOGRAM, A PROXIMAL ENDOLEAK WAS NOTICED AGAIN. THE PHYSICIAN USED A COOK BALLOON TO REINFORCE THE PROXIMAL SEAL AND THE ENDOLEAK. DURING THE INFLATION, THE PATIENT'S AORTA RUPTURED. THE PATIENT WAS IMMEDIATELY CONVERTED TO AN OPEN PROCEDURE TO REMOVE THE TRUNK-IPSILATERAL LEG COMPONENT. THE CONTRALATERAL LEG COMPONENT REMAINED IN THE PATIENT. DURING THE OPEN CONVERSION PROCEDURE, THE PATIENT EXPIRED. NO AUTOPSY WAS PERFORMED BUT THE PHYSICIAN STATED THE CAUSE OF DEATH WAS FROM THE RUPTURED AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 7719483

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death