BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 10862735 · Received November 18, 2020

    Report

    Report Number
    3013164176-2020-01080
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    August 4, 2020
    Report Date
    March 4, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618545
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: CATALOG #CEB231410A/ SERIAL #(B)(6)/ UDI #(B)(4) WHICH IS CAPTURED IN MANUFACTURER REPORT # 3013164176-2020-01081. H.6. METHOD CODE 3: CODE 4112 - IMAGES WERE PROVIDED, AND AN IMAGING EVALUATION WAS PERFORMED. H.6. RESULTS CODE 3: CODE 3207 - THE IMAGING EVALUATION FOUND THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2020. THERE APPEARS TO BE A SEPARATION OF THE DISTAL CONTRALATERAL LIMB AND THE PROXIMAL IBE COMPONENT IN THE LEFT COMMON ILIAC ARTERY (LCI). THE LENGTH FROM THE DISTAL LIMB TO THE PROXIMAL IBE APPEARS TO BE ~4CM, BY OUTER CURVE LENGTH. LCI ANGULATION AT THE DEVICE SEPARATION APPEARS TO BE 97 DEGREES. H.6. CONCLUSIONS CODE 1 REMAINS UNCHANGED. H.6. CONCLUSIONS CODE 2 REMAINS UNCHANGED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, COMPONENT MIGRATION.

    Additional Manufacturer Narrative · 0

    B4: DESCRIPTION OF EVENT: ADDITIONAL INFORMATION REGARDING REINTERVENTION ADDED. H6: INVESTIGATION CONCLUSIONS CODES REMAIN UNCHANGED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, COMPONENT MIGRATION.

    Description of Event or Problem · 0

    ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED. THE SYSTEM WAS RELINED FROM THE CONTRALATERAL LEG GATE TO THE ILIAC BRANCH COMPONENT FLOW DIVIDER USING TWO ADDITIONAL CONTRALATERAL LEG COMPONENTS (PLC14100 AND PLC271200). THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: ASKED BUT UNAVAILABLE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, COMPONENT MIGRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT CT FOLLOW UP ON (B)(6) 2020 REVEALED COMPLETE SEPARATION OF THE GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT AND THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT. THE DEVICE SEPARATION WAS REPORTEDLY SUSPECTED TO BE CAUSED BY THE PATIENT'S ANATOMICAL TORTUOSITY AND REMODELING. REPORTEDLY NO ANEURYSM ENLARGEMENT WAS NOTED. IT WAS REPORTED THAT REINTERVENTION IS PLANNED, BUT HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324820 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC271200 00733132618545

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention