BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3203710 · Received June 25, 2013

    Report

    Report Number
    2017233-2013-00405
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    December 30, 2011
    Report Date
    June 10, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN PT ETIOLOGIES WITH INTRAMURAL HEMATOMAS OR PENETRATING ULCERS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT UNDERWENT REPAIR OF AN INTRAMURAL HEMATOMA WITH A PENETRATING ULCER AND WAS IMPLANTED WITH A GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS. AFTER COMPLAINING OF CHEST PAIN, ON (B)(6) 2011, THE PT UNDERWENT A FOLLOW-UP COMPUTED TOMOGRAPHY THAT REVEALED PROXIMAL EXTENSION OF THE PENETRATING ULCER. ON (B)(6) 2011, THE PT UNDERWENT A REINTERVENTION AND WAS IMPLANTED WITH A SECOND CONFORMABLE TAG DEVICE, PROXIMAL TO THE FIRST DEVICE. THE PT TOLERATED THE PROCEDURE AND WAS DISCHARGED, ON AN UNKNOWN DATE. ON (B)(6) 2011, A FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), REVEALED A PENETRATING ULCER PROXIMAL TO THE OTHER TWO PREVIOUSLY IMPLANTED DEVICES. ON (B)(6) 2011, THE PT WAS RETURNED TO THE OPERATING ROOM, WHERE AN ARTERIOGRAM CONFIRMED CORRECT PLACEMENT OF THE TWO PREVIOUS DEVICES AND A THIRD CONFORMABLE TAG DEVICE WAS IMPLANTED PROXIMAL TO THE OTHER TWO PREVIOUS DEVICES TO TREAT ANOTHER PROXIMAL PENETRATING ULCER. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287749 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8921887A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R SIMVASTATIN| METOPROLOL| ASPIRIN