BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4120526 · Received September 26, 2014

    Report

    Report Number
    2017233-2014-00506
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    May 12, 2010
    Report Date
    October 16, 2014
    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

    ADDED PREEXISTING MEDICAL CONDITIONS. UPDATED RESULTS AND CONCLUSIONS CODE: 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, AS THE FIRST-STAGE PROCEDURE TO TREAT A THORACIC AORTIC ANEURYSM, TOTAL AORTIC ARCH REPLACEMENT ALONG WITH ELEPHANT TRUNK PROCEDURE WAS PERFORMED. ON (B)(6) 2010, AS THE SECOND-STAGE PROCEDURE TO TREAT A THORACIC AORTIC ANEURYSM, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING GORE® TAG® THORACIC ENDOPROSTHESES (TGT3420/7206124, TGT4020/7403796). PRIOR TO THE PROCEDURE, A BARE METAL STENT WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THE PROCEDURE, THE PATIENT DEVELOPED PARAPLEGIA. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH MEDICATION AND THE PHYSICIAN STARTED THE PATIENT ON REHABILITATION. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT THE PARAPLEGIA REMAINED. ON (B)(6) 2010, SIX MONTH FOLLOW-UP EXAMINATION SHOWED THAT THE PARAPLEGIA REMAINED. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO RENAL DYSFUNCTION AT A DIFFERENT HOSPITAL. IT WAS REPORTED THAT THE RENAL DYSFUNCTION WAS NOT DEVICE- OR PROCEDURE-RELATED. NO FURTHER INFORMATION REGARDING THE PATIENT'S DEATH IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600998 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7206124

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Disability