BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4870274 · Received June 26, 2015

    Report

    Report Number
    2017233-2015-00378
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    November 20, 2010
    Report Date
    June 15, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR PROCEDURE USING GORE® TAG® THORACIC ENDOPROSTHESES (TGT3715/8005920, TGT4020/8030667) TO REPAIR RUPTURE OF A DESCENDING THORACIC AORTIC ANEURYSM. NO ISSUES WERE OBSERVED DURING THE PROCEDURE. ON (B)(6) 2010, THE PATIENT DEVELOPED PARAPLEGIA. THE CAUSE OF THE PARAPLEGIA WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS NOT TREATED, AND WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2011, SIX MONTH FOLLOW-UP EXAMINATION SHOWED THAT THE PARAPLEGIA REMAINED. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO ACUTE RENAL FAILURE. IT WAS REPORTED THAT THE CAUSE OF THE RENAL FAILURE WAS DUE TO INFECTION TO NOROVIRUS, AND THAT THE RENAL FAILURE WAS NOT DEVICE OR PROCEDURE-RELATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416372 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8005920

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| S