BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 14242605 · Received April 28, 2022

    Report

    Report Number
    3013164176-2022-01361
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 20, 2022
    Report Date
    August 18, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618729
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: BACK PAIN, HYPERTENSION, TIA. PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: ULTRAM, LOVENOX, IRON SUPPLEMENT, FLOMAX, TYLENOL.

    Additional Manufacturer Narrative · 0

    IMAGES WERE PROVIDED TO GORE AND AN EVALUATION SHOWED THE FOLLOWING: THE PROXIMAL MAIN BODY APPEARS WELL APPOSED WITH NO EVIDENCE OF A TYPE 1A ENDOLEAK. THERE APPEARS TO BE A COUPLE INSTANCES OF LUMBAR ARTERIES COMMUNICATING WITH THE ABDOMINAL ANEURISM, INDICATING THE PRESENCE OF TYPE 2 ENDOLEAKS. THERE IS CONTRAST VISUALIZED OUTSIDE THE L CONTRALATERAL LIMB CONSISTENT WITH A TYPE 1B ENDOLEAK. THERE APPEARS TO BE LESS THAN 1CM IMPLANTED IN THE EXTERNAL ILIAC ARTERY. LOWEST RENAL TO L HYPOGASTRIC LENGTH ~ 161MM MINIMUM, 187MM CENTERLINE. THERE APPEARS TO BE THE FOLLOWING: R IPSI: 28.5MM X 14.5MM X 12CM, R EXTENSION: NOT MEASURED, L CONTRALATERAL LIMB #1 ~ 14.5MM X 12CM, L CONTRALATERAL LIMB #2 ~ 16MM X 9.5CM. TOTAL TREATMENT LENGTH, LOWEST RENAL TO THE DISTAL END OF THE 2ND LEFT CONTRALATERAL LIMB ~191MM.

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE®EXCLUDER® AAA ENDOPROSTHESIS STATES, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA) AND A SMALL ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS AND NO ENDOLEAK VISUALIZED. ON (B)(6) 2022, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY AND A DISTAL TYPE I ENDOLEAK WAS VISUALIZED. THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS PLACED TO EXTEND COVERAGE AND RESOLVED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE, NO ANEURYSM ENLARGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100966 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC161400 00733132618729

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male