BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5245325 · Received November 24, 2015

    Report

    Report Number
    2017233-2015-00832
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    August 31, 2009
    Report Date
    November 9, 2015
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. - REPORTABILITY OF PATIENT¿S DEATH. THE PATIENT SUFFERED FROM RENAL FAILURE 4 DAYS POST INITIAL IMPLANT OF THE DEVICES AND DEVELOPED BOWEL NECROSIS 11 DAYS POST INITIAL IMPLANT. NEITHER VESSEL OBSTRUCTION BY OUR DEVICES NOR THE VESSEL THROMBOSIS DID OCCUR AFTER THE INITIAL IMPLANT PROCEDURE, AND FOR THIS ASPECT, THIS PORTION OF EVENT IS NOT REPORTABLE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TG3415/06790866 AND TG3715/6960616) AND A NON-GORE ENDOPROSTHESIS. DURING THE IMPLANT PROCEDURE, THE LEFT COMMON ILIAC ARTERY (LCIA) WAS THROMBO-EMBOLIZED. REPORTEDLY, THE PATIENT HAD THROMBUS AROUND THE ABDOMINAL AORTIC ANEURYSM AND THE THROMBUS SPREAD, OCCLUDING THE LCIA. THE ABDOMINAL AORTA WAS SURGICALLY REPLACED TO REPAIR THE THROMBOEMBOLISM OF THE LCIA. THE ESTIMATED AMOUNT OF BLOOD LOSS DURING THE IMPLANT PROCEDURE WAS MORE THAN 4800ML. ON (B)(6) 2009, THE PATIENT SUFFERED FROM PARAPLEGIA, AND SPINAL DRAINAGE, MEDICATIONS AND VASOPRESSORS WERE GIVEN TO THE PATIENT. ON (B)(6) 2009, THE PATIENT SUFFERED FROM RENAL FAILURE, AND A CONTINUOUS HEMODIAFILTRATION (CHDF) WAS PERFORMED. ON (B)(6) 2009, BOWEL NECROSIS WAS REVEALED AND LARGE INTESTINE AND A PART OF SMALL INTESTINE WERE SURGICALLY REMOVED. ON THE SAME DAY, THE PATIENT EXPIRED DUE TO RENAL FAILURE AND BOWEL NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777041 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06790866

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R| S TG3715/6960616