BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4110842 · Received September 23, 2014

    Report

    Report Number
    2017233-2014-00448
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 30, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    PATIENT MEDICATIONS INCLUDE CLOPIDOGREL, TRAZODONE, ATORVASTATIN, POTASSIUM CHLORIDE, LANSOPRAZOLE, METOPROLOL SUCCINATE, BUSPIRONE HCL, OXYCODONE, MORPHINE, AND CYANOCOBALAMIN.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS REPORTEDLY LOST TO FOLLOW UP. ON (B)(6) 2014, THE PATIENT PRESENTED TO THE HOSPITAL, AND FOLLOW UP IMAGING REPORTEDLY IDENTIFIED 2 CM DISTAL MIGRATION OF THE TRUNK-IPSILATERAL LEG COMPONENT AND A PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THE PATIENT¿S PROXIMAL NECK DILATED OVER TIME, CAUSING A LOSS OF SEAL ON THE TRUNK. THERE WAS NO REPORTED EVIDENCE OF ANEURYSM ENLARGEMENT. ON (B)(6) 2014, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE MIGRATION AND ENDOLEAK. TWO AORTIC EXTENDER COMPONENTS WERE IMPLANTED FOR PROXIMAL EXTENSION ON THE TRUNK. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590046 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7867650

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R