BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3131296 · Received May 14, 2013

    Report

    Report Number
    2953161-2013-00064
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 22, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PT WAS EMERGENTLY IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. ALTHOUGH A FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK, THE PHYSICIAN DECIDED TO MONITOR THE PT AND COMPLETED THE PROCEDURE. THE CAUSE OF THE ENDOLEAK WAS ATTRIBUTED TO EXTREME TORTUOUSITY AND SHORT PROXIMAL LANDING ZONE. ON (B)(6) 2013, THREE MONTH FOLLOW-UP IMAGE REVEALED THAT THE PROXIMAL TYPE 1 ENDOLEAK PERSISTED AND WAS ASSOCIATED WITH ANEURYSM ENLARGEMENT OF MORE THAN 5MM. ON (B)(6) 2013, AN ADDITIONAL PROCEDURE WAS UNDERTAKEN TO REPAIR THE PERSISTENT ENDOLEAK. A STENT GRAFT OF ANOTHER MFR (ENDURANT, AORTIC EXTENSION, 23MMX49MM) WAS IMPLANTED. THE ENDOLEAK WAS RESOLVED AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213829 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 9621507

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R