BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 10628025 · Received October 5, 2020

    Report

    Report Number
    3013164176-2020-01051
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 23, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618651
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGES WERE PROVIDED TO GORE AND EVALUATION SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2020. AORTIC DIAMETER, POST IMPLANTATION AT THE BIFURCATION, APPEARS TO BE 18MM. FLOW LUMEN DIAMETER AT THE BIFURCATION ON THIS TIME POINT APPEARS TO BE ~11MM. THE CONTRALATERAL LIMB APPEARS TO BE OCCLUDED BEGINNING AT THE LEVEL OF THE FLOW DIVIDER AND EXTENDING TO THE DISTAL END OF THE LIMB IN THE LCI. THE CONTRALATERAL LIMB APPEARS TO BE COMPRESSED AT THE LEVEL OF THE AORTIC BIFURCATION. CONTRAST APPEARS TO RECONSTITUTE DISTAL TO THE END OF THE CONTRALATERAL LIMB IN THE LCI.

    Description of Event or Problem · 0

    ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO RELINE THE OCCLUDED LIMB. AGIOPLASTY OF THE BIFURCATION WAS PERFORMED WITH TWO 10MM X 40MM KISSING BALLOONS. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, FOLLOW-UP IMAGING DETERMINED AN OCCLUSION OF THE CONTRALATERAL LIMB. IMAGING SHOWED THE CONTRALATERAL LIMB AT THE LEVEL OF THE BIFURCATION APPEARED COMPRESSED AND CRUSHED. A REINTERVENTION IS PLANNED, YET NOT YET SCHEDULED WHEREIN THE PHYSICIAN PLANS TO LYSE THE PATIENT AND RELINE THE LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093417 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC141400 00733132618651

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O| R