BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4872350 · Received June 26, 2015

    Report

    Report Number
    2017233-2015-00379
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    May 28, 2015
    Report Date
    July 8, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES ¿RECOMMENDED ENDOPROSTHESIS OVERSIZING RELATIVE TO THE AORTIC VESSEL IS APPROXIMATELY (B)(6)¿. 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 ENDOLEAK.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND INVOLVED: PXC271000/9920795 AND PXC231000/9743916. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESES LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT EMERGENT TREATMENT OF AN RUPTURED ABDOMINAL AORTIC ANEURYSM WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2015, FOLLOW-UP IMAGING IDENTIFIED A CONTRALATERAL LEG COMPONENT (LOT NUMBER UNKNOWN) MIGRATED 4CM PROXIMALLY CREATING A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THE MIGRATION OF THE DEVICE WAS DUE TO UNDERSIZING. IT WAS REPORTED ON THE SAME DAY, AN AORTOUNIILIAC WITH A FEMORAL-FEMORAL BYPASS WAS PERFORMED TO TREAT THE MIGRATION OF THE DEVICE. FINAL ANGIOGRAPHY SHOWED COMPLETE EXCLUSION OF THE ANEURYSM, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415106 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9844836

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R