BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1941784 · Received December 21, 2010

    Report

    Report Number
    2017233-2010-00566
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 17, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, AFTER DEPLOYMENT, USE THE GORE TRI-LOBE BALLOON CATHETER TO SMOOTH AND SEAT THE ENDOPROSTHESIS AGAINST THE AORTIC WALL IN THE DISTAL AND PROXIMAL NECKS. IN ADDITION, THE INSTRUCTIONS FOR USE INDICATE ' MATERIALS REQUIRED FOR DEVICE PLACEMENT', GORE TRI-LOBE BALLOON CATHETER.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT UNDERWENT REPAIR OF A THORACIC AORTIC ANEURYSM. THE PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS AND THE DEVICE WAS BALLOONED USING A CODA BALLOON. FINAL ANGIOGRAM REVEALED A TYPE A DISSECTION. THE PT WAS CONVERTED TO OPEN REPAIR WHERE A DACRON FOUR WAY GRAFT WAS IMPLANTED AND ANASTOMOSIS TO THE IMPLANTED GORE TAG THORACIC ENDOPROSTHESIS. THE PT TOLERATED THE PROCEDURE. THE PT HAS A FRAGILE AORTA AND HAD A SLIGHT DISSECTION PRIOR TO THE PROCEDURE. THE CODA BALLOON WAS NOT OVER INFLATED; HOWEVER, THE PT'S AORTA WAS FRAGILE AND NOT ABLE TO WITHSTAND BALLOONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG426 7375501

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R