BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2960415 · Received February 6, 2013

    Report

    Report Number
    2017233-2013-00051
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ATTEMPTS TO ACQUIRE INFO FOR THIS FORM WERE MADE BY GORE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PATIENT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A CHRONIC DISSECTION WITH A THORACIC ANEURYSM COMPONENT. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN DEPLOYED THE DEVICE PROXIMAL TO WHERE HE INTENDED THE DEVICE TO LAND. THE DEVICE WAS DEPLOYED AND PARTIALLY COVERED THE LEFT SUBCLAVIAN ARTERY. IN ADDITION THERE WAS ALSO LACK OF CIRCUMFERENTIAL DEVICE APPOSITION TO THE AORTIC WALL REPORTED. THE PHYSICIAN ATTEMPTED TO PULL THE CTAG DEVICE DISTAL FROM THE LANDED POSITION, BUT THE DEVICE WOULD NOT MOVE. HE THEN CHOSE TO TAKE A WAIT AND WATCH APPROACH DUE TO THE FINAL ANGIOGRAM SHOWING SOME BLOOD PROFUSION TO THE LEFT SUBCLAVIAN ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49488 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 9456720

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention