BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4063627 · Received September 5, 2014

    Report

    Report Number
    2017233-2014-00458
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    August 7, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT MEDICATIONS INCLUDE ASPIRIN, SERTRALINE, CLOPIDOGREL, EZETIMIBE, CEPHALEXIN, IRBESARTAN, AND SALBUTAMOL. A REVIEW OF THE MANUFACTURING PAPERWORK FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. SPECIFICALLY, THE IFU WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES (RMT281416/10205125 AND PXC141200/10424276) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A COMPLETION ANGIOGRAPH REPORTEDLY REVEALED A TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY. THE PATIENT TOLERATED THE PROCEDURE, AND THE PHYSICIAN ELECTED TO MONITOR THE TYPE II ENDOLEAK. BETWEEN (B)(6) 2013 AND (B)(6) 2014, FOLLOW-UP ULTRASOUND AND COMPUTED TOMOGRAPHIC IMAGES CONFIRMED THE TYPE II LEAK. THE ANEURYSM SAC HAD ENLARGED IN DIAMETER FROM 50 MM TO 58 MM. ON (B)(6) 2014, ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK. ON THE SAME DAY, THE PATIENT UNDERWENT COIL EMBOLIZATION OF THE ANEURYSMAL SAC. COMPLETION ANGIOGRAPHY REPORTEDLY SHOWED A SMALL AMOUNT OF CONTRAST BETWEEN THE GRAFT AND AORTIC WALL AT THE VERY SUPERIOR INFRARENAL NECK SEGMENT, INDICATING A PARTIALLY UNRESOLVED TYPE I LEAK. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INTERVENTION IS PLANNED AT THIS TIME. ACCORDING TO THE REPORT, ANEURYSMAL SAC SIZE IS STABLE AT 58 MM. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT WITH ULTRASOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545001 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10205125

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R