BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3001604 · Received March 7, 2013

    Report

    Report Number
    2017233-2013-00122
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS WERE REQUESTED AND NOT PROVIDED TO GORE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT ON (B)(6) 2013, THERE WAS AN ENDOVASCULAR TREATMENT OF A NEW PRIMARY DISSECTION USING CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. ONE OF THE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS WAS USED AS A DISTAL EXTENSION AND WAS DEPLOYED AS INTENDED PROXIMAL TO THE MESENTERIC ARTERY. THE FINAL ANGIOGRAM SHOWED SUCCESSFUL EXCLUSION OF THE ENTRY TEARS AND THE DISSECTION, BUT DISTALLY THE MESENTERIC ARTERY WAS COVERED INADVERTENTLY. THE PATIENT WAS TREATED SURGICALLY WITH A BYPASS FROM THE ILIAC ARTERY TO THE MESENTERIC ARTERY TO AVOID MESENTERIC ISCHEMIA. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97095 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R