BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3143031 · Received May 23, 2013

    Report

    Report Number
    2017233-2013-00327
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 26, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CTAG DEVICE INCLUDED IN THIS REPORT: TGU212110/10888813. A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE GORE TAG THORACIC ENDOPROSTHESIS IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA. PER IFU, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK AND REOPERATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH TWO CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES TO TREAT AN AORTIC COARCTATION. ON (B)(6) 2013, COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN INDICATED THE PT'S COARCTATION HAD CAUSED THE STENT GRAFT TO MIGRATE DISTALLY (DISTANCE UNK), CAUSING THE ENDOLEAK. ON (B)(6) 2013, THE PT WAS IMPLANTED WITH AN ADDITIONAL CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT THE TYPE I ENDOLEAK. A FINAL ANGIOGRAPHIC RUN SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228547 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 9936968

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R