BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM

    MDR report key: 2142918 · Received June 22, 2011

    Report

    Report Number
    2017233-2011-00300
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    April 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THIS PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT A TRUNK-IPSILATERAL LEG COMPONENT FEATURING C3 DELIVERY SYSTEM MOVED 8 MM DISTAL TO THE LOWEST RENAL ARTERY DURING DEPLOYMENT DUE TO SEVERE PROXIMAL NECK ANGLE AND TORTUOSITY. THE PHYSICIAN ATTEMPTED TO RECONSTRAIN THE DEVICE FOR REPOSITIONING, BUT THE DEVICE WOULD NOT ADVANCE DUE TO THE ANGULATION AND TORTUOSITY. IT WAS REPORTED THE PHYSICIAN DID NOT WANT TO FORCE THE DEVICE INTO PLACEMENT, SO HE ELECTED TO LEAVE THE DEVICE 8 MM FROM THE INTENDED POSITION. FINAL ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK; HOWEVER, THE PHYSICIAN REPORTEDLY ELECTED TO LEAVE THE ENDOLEAK AND MONITOR THE PT. THE PT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE ENDOLEAK DID NOT RESOLVE; HOWEVER, NO ANEURYSM ENLARGEMENT WAS IDENTIFIED. ON (B)(6), 2011, AN ADD'L PROCEDURE WAS PERFORMED TO TREAT THE PERSISTENT PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN PLACED AN AORTIC EXTENDER COMPONENT FOR PROXIMAL EXTENSION, AND FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES, INC. WLG425 8365282

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R FLOMAX| SIMVASTATIN| METOPROLOL| FOSSAMAX| ASPIRIN