BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122493 · Received May 14, 2013

    Report

    Report Number
    2953161-2013-00066
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC141200/(B)(4). RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED, A COMPUTER TOMOGRAPHY (CT) DATED (B)(6) 2010 POST EVAR SCAN SHOWED A SMALL TYPE II ENDOLEAK. THE ANEURYSM CONTINUED TO GROW SIGNIFICANTLY DESPITE TREATMENT OF THE TYPE II ENDOLEAK. THE PHYSICIAN BELIEVES THE CAUSE OF THE ISSUE WAS INADEQUATE SEAL AT THE PROXIMAL FIXATION SITE WITH PRESSURE TRANSDUCTION TO THE ANEURYSM SAC. ON (B)(6) 2012, THE PHYSICIAN INTERVENED AND COILED THE INFERIOR MESENTERIC ARTERY AND THE DISTAL RIGHT LUMBAR ARTERY. THIS ATTEMPT WAS UNSUCCESSFUL; THERE WAS STILL AN INDETERMINATE ENDOLEAK PRESENT. IT WAS REPORTED THAT CURRENT IMAGES REVEALED AN INDETERMINATE TYPE II OR PROXIMAL TYPE I ENDOLEAK. THERE HAS BEEN ANEURYSM ENLARGEMENT OF 1 MM PER MONTH OVER THE PAST SEVEN MONTHS. A RECENT COMPUTED TOMOGRAPHY (DATE UNK) REVEALED A LARGE TYPE I A ENDOLEAK WITH NO OPTIONS FOR EXTENSION. ON (B)(6) 2013, THERE WAS A REINTERVENTION, THE PHYSICIAN TREATED THE ENDOLEAK BY USING FIVE HELICAL ENDOANCHORS ON THE PROXIMAL PORTION OF THE GORE GRAFT, THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212184 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 7709988

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ASPIRIN| NORVASC| AVAPRO| PRADAXA| VITAMIN D| COLCHICINE| ALLOPURINOL| MULTI VITAMINS| LIPITOR| METOPROLOL| METFORMIN