BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3881139 · Received June 18, 2014

    Report

    Report Number
    2017233-2014-00323
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL IMPLANTED CTAG® DEVICES: - TGU454520/12568688; - TGU454520/12279416. PATIENT MEDICATIONS INCLUDE CELEXA, SYNTHROID, SPIRIVA, LOPRESSOR, ADVAIR, XANAX, CALCIUM, MEVACOR, PROAIR, MULTIVITAMIN, MUCINEX, MOTRIN, AND VITAMIN D. EVAL: A REVIEW OF THE MANUFACTURING PAPERWORK FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO VASCULAR TRAUMA (E.G., ILIO-FEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH THREE CONFORMABLE GORE® TAG® ENDOPROSTHESES. THE PROXIMAL PORTION OF THE STENT GRAFT SYSTEM WAS DEPLOYED DISTAL TO THE BRACHIOCEPHALIC ARTERY. PRIOR TO THE PROCEDURE, THE PHYSICIAN PERFORMED A SURGICAL DEBRANCHING OF THE LEFT SUBCLAVIAN ARTERY, AND STENTED THE LEFT COMMON CAROTID ARTERY. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO BE HYPOTENSIVE. A COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY REVEALED A RIGHT RETROPERITONEAL HEMATOMA CONTRIBUTING TO HEMORRHAGIC SHOCK. ACCORDING TO THE PHYSICIAN, THE HEMATOMA WAS NOT DEVICE-RELATED, AND WAS LIKELY DUE TO INADEQUATE POST-OPERATIVE RESUSCITATION WITH BLOOD PRODUCTS. THE PATIENT'S INR WAS ELEVATED TO 2.8, AND PLATELET COUNT WAS 37. THE PHYSICIAN CONSIDERED THIS BLEEDING TO BE "MEDICAL" AS OPPOSED TO "SURGICAL" BLEEDING. ADDITIONAL BLOOD PRODUCTS AND A NEO-SYNEPHRINE DRIP WERE ADMINISTERED. ON (B)(6) 2014, A SURGICAL EVACUATION WAS PERFORMED TO TREAT THE HEMATOMA. ACCORDING TO REPORT, THE EVACUATION PARTIALLY RESOLVED THE ISSUE, BUT THE PATIENT¿S CLOTTING ABILITY REMAINED UNCONTROLLED. THE PHYSICIAN INDICATED THAT THESE EVENTS WERE RELATED TO THE PROCEDURE AND NOT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358529 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12568706

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R