BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4839203 · Received June 11, 2015

    Report

    Report Number
    2017233-2015-00353
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 26, 2015
    Report Date
    July 21, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) IS BEING CONDUCTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.EXCLUDER® AAA ENDOPROSTHESIS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENTPLEASE SEE RESULTS OF IMAGING EVALUATION

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. NO STERILIZATION REVIEW WAS PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR RE-INTERVENTION FOR A LEFT COMMON ILIAC (LCI) ARTERY ANEURYSM AND WAS IMPLANTED WITH THREE ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND A LEFT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR RE-INTERVENTION FOR ENLARGEMENT OF THE LEFT COMMON ILIAC (LCI) ARTERY ANEURYSM AND WAS IMPLANTED WITH THREE ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES. THERE WAS NO REPORTED ENDOLEAK AND NO ENLARGEMENT OF THE ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381332 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10115672

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R PXC231400/