BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3840033 · Received May 30, 2014

    Report

    Report Number
    2017233-2014-00282
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 25, 2014
    Report Date
    June 3, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALSO IMPLANTED ON 3/25/2014: PXC141000J/12142840, PXC181000J/12039603, PXC181400J/11541565 RESULTS PENDING COMPLETION OF EVALUATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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 ENDOLEAKS AND ANEURYSM RUPTURE. ADDITIONALLY, USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR REPAIR OF AN IMPENDING RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. FINAL ANGIOGRAM SHOWED POSSIBLE TYPE 2 ENDOLEAK OR TYPE 3 ENDOLEAK FROM THE DEVICE JUNCTION, BUT THE PROCEDURE CONCLUDED WITH THE ENDOLEAKS TO BE MONITORED. ON (B)(6) 2014, THE PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR REPAIR OF THE RUPTURED ABDOMINAL AORTIC ANEURYSM. A CONTRALATERAL LEG COMPONENT WAS IMPLANTED AT THE JUNCTION AREA OF THE CONTRALATERAL GATE TO REPAIR THE TYPE 3 ENDOLEAK. THE ANGIOGRAM SHOWED THE RESOLUTION OF THE TYPE 3 ENDOLEAK AND A PERSISTENT TYPE 2 ENDOLEAK, WHICH WAS UNTREATED TO BE MONITORED. ON (B)(6) 2014, THE PATIENT¿S ABDOMINAL AORTIC ANEURYSM RUPTURED AGAIN DUE TO THE PERSISTENT TYPE 2 ENDOLEAK THIS TIME. THE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE EXPLANTED AND THE PATIENT UNDERWENT SURGICAL CONVERSION USING A VASCULAR GRAFT. IT WAS REPORTED THAT THE PATIENT HAD A TORTUOUS PROXIMAL NECK. HOWEVER, THE DEVICE OVERLAP LENGTH WAS NOT SUFFICIENT TO CORRESPOND TO THE BEND. AS OF (B)(6) 2014, THE PATIENT IS STILL IN THE HOSPITAL BUT IS GETTING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319582 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12106279

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R