BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 8125587 · Received December 3, 2018

    Report

    Report Number
    3007284313-2018-00338
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    July 10, 2018
    Report Date
    December 3, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132622443
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NAME AND ADDRESS.

    Additional Manufacturer Narrative · 1

    MEDICATION'S - ANTICOAGULANT MEDICATIONS (TYPE UNKNOWN). IMAGES WERE SENT TO GORE FOR EVALUATION: 3D RECONSTRUCTION FROM CT DATED (B)(6) 2018 ILLUSTRATING A PATENT LII. AXIAL IMAGES FROM CT DATED (B)(6) 2018 ILLUSTRATING A PATENT LII. CENTERLINE RECONSTRUCTION FROM THE CT DATED (B)(6) 2018 ILLUSTRATES MINIMAL AMOUNTS OF THE THROMBUS PRESENT IN THE ABDOMINAL AORTA. CENTERLINE RECONSTRUCTION FROM THE CT DATED (B)(6) 2018 ILLUSTRATES SIGNIFICANT THROMBUS PRESENT IN THE ABDOMINAL AORTA AND THE LCI AND LII APPEAR TO BE OCCLUDED. AXIAL IMAGES FROM CT DATED (B)(6) 2018 ILLUSTRATE THAT THE LCI AND LII APPEAR TO BE OCCLUDED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO OCCLUSION OF DEVICE OR NATIVE VESSEL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM AND A COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON AN UNKNOWN DATE, IMAGING REPORTEDLY IDENTIFIED A DEVICE (UNKNOWN) WAS CLOTTED OFF. ON (B)(6) 2018, IMAGING CONFIRMED CLOTTING OFF OF PATIENT'S LEFT SIDE (TRUNK-IPSILATERAL LEG COMPONENT DOWN TO THE INTERNAL ILIAC COMPONENT (HGB) AND ILIAC BRANCH COMPONENT (CEB) DEVICES). THE PHYSICIAN BELIEVES A POSSIBLE CAUSE OF THE ADVERSE EVENT IS THE PATIENT NOT TAKING HIS ANTICOAGULANT MEDICATIONS. THE PATIENT REPORTEDLY UNDERWENT AN UNSUCCESSFUL THROMBECTOMY. IT WAS REPORTED THE PHYSICIAN DECIDED TO PERFORM A FEMOROFEMORAL BYPASS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964684 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 16580050 00733132622443

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R