BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOREｮ EXCLUDERｮ AAA ENDOPROSTHESIS

    MDR report key: 4201656 · Received October 27, 2014

    Report

    Report Number
    2017233-2014-00554
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    May 8, 2009
    Report Date
    December 9, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO IMPROPER COMPONENT PLACEMENT AND RENAL ARTERY OCCLUSION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO IMPROPER COMPONENT PLACEMENT AND RENAL ARTERY OCCLUSION. RESULTS PENDING COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: SHINGO ISSIKI, ET AL. "A CASE REPORT: TEMPORARY COVERAGE OF LEFT RENAL ARTERY DURING ENDOVASCULAR AORTIC REPAIR USING THE GORE EXCLUDER." JOURNAL OF JAPAN SOCIETY FOR VASCULAR SURGERY, 2009, VOL.18 NO.6 PAGE651. ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE; EXCLUDER; AAA ENDOPROSTHESES. AS THE BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL EDGE OF THE TRUNK IPSILATERAL LEG COMPONENT, THE DEVICE INADVERTENTLY MOVED PROXIMALLY AND COVERED THE LEFT RENAL ARTERY COMPLETELY. THE PHYSICIAN INFLATED THE BALLOON IN THE IPSILATERAL LEG AND SUCCEEDED IN PULLING THE DEVICE DOWNWARD TO RESTORE THE BLOOD FLOW INTO THE RENAL ARTERY. THE FINAL ANGIOGRAM SHOWED NO DELAY IN THE FLOW. THE PROCEDURE CONCLUDED WITHOUT ANY OTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682062 GOREｮ EXCLUDERｮ AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06516911

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention