BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5904183 · Received August 25, 2016

    Report

    Report Number
    2017233-2016-00708
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    May 4, 2016
    Report Date
    September 6, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXA260300/06184864, PXC201000/06624268 AND PXC201400/7002674). (B)(4). CONCOMITANT MEDICAL PRODUCTS: THE PATIENT¿S MEDICATIONS INCLUDE; ALLOPURINOL, LEVOTHYROXINE, ASPIRIN, NORTRIPTYLINE, OMEPRAZOLE, PLAVIX, ZYRTEC, TRIAMTERENE-HYDROCHLOROTHIAZIDE AND CRESTOR.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), STATES ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO, ENDOLEAK AND CONTINUED ANEURYSM ENLARGEMENT. FURTHER, 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 UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2016, FOLLOW-UP IMAGING IDENTIFIED A TYPE II ENDOLEAK CONTINUING TO BE PERFUSED FROM THE INFERIOR MESENTERIC ARTERY AND MULTIPLE INTERCOSTAL LUMBAR ARTERIES. REPORTEDLY, THE DIAMETER OF THE ANEURYSM MEASURED 14.4 CM, COMPARED TO A MEASUREMENT OF 6.7 CM IN 2010. ON (B)(6) 2016, AN OPEN SURGICAL REPAIR WAS PERFORMED WHEREBY ALL FOUR PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESES WERE EXPLANTED DUE TO CONTINUING ANEURYSM ENLARGEMENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555520 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06620142

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R