BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1780752 · Received July 27, 2010

    Report

    Report Number
    2017233-2010-00352
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 26, 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. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET PRE-RELEASE SPECIFICATIONS. FURTHER INFORMATION AND IMAGES WERE REQUESTED. ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK, TRANSIENT ISCHEMIA, VASCULAR TRAUMA (E.G., ILIO-FEMORAL VESSEL DISSECTION) AND REOPERATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC DESCENDING AORTIC ANEURYSM. A PROXIMAL TYPE I ENDOLEAK WAS DISCOVERED DURING THE PROCEDURE. ANOTHER GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED. THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY COVERED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, AN AORTIC DISSECTION FROM THE DISTAL FLARE OF THE TAG DEVICE TO THE COMMON ILIAC ARTERY WAS NOTICED. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. ON (B)(6) 2010, THE PATIENT DEVELOPED ORGAN ISCHEMIA AND LOWER EXTREMITY ISCHEMIA. TWO ADDITIONAL GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED. THE ENTRY HOLE WAS SEALED. THE PATIENT TOLERATED THE PROCEDURE. THE IMAGES TAKEN AFTER THE PROCEDURE SHOWED EXPANSION OF THE TRUE LUMEN AND SHRINKAGE OF THE FALSE LUMEN. THE PATIENT IS BEING MONITORED IN ICU. FURTHER INFORMATION AND IMAGES WERE REQUESTED.

    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 WLG326 7791985

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R