BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2782061 · Received October 1, 2012

    Report

    Report Number
    2017233-2012-00679
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 16, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATES THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE: NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS). ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: TGU454520/ 10399769 AND TGU404020/ 9944710.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THIS PATIENT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM (TAA). IT WAS REPORTED A CEREBROSPINAL DRAIN WAS PERFORMED PRIOR TO THIS SURGERY. THE CURRENT TAA BEING TREATED WAS A "DUMBBELL-SHAPED" AND EXTENDED 39 CM OF NATIVE AORTA JUST DISTAL FROM THE SUBCLAVIAN ARTERY TO JUST SUPERIOR OF THE CELIAC ARTERY. THE PHYSICIAN REPORTEDLY IMPLANTED THE MOST PROXIMAL TAG DEVICE IN HEALTHY AORTA DISTAL TO THE PREVIOUSLY IMPLANTED GRAFT AND THE MOST DISTAL TAG DEVICE REACHED JUST SUPERIOR OF THE CELIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. APPROXIMATELY 36 HOURS POST PROCEDURE, ON (B)(6) 2012 THE PATIENT WAS EXPERIENCING PARAPLEGIA. THE PATIENT HAD NO SENSORY BUT FELT PRESSURE DURING THE NEUROLOGIC EXAM. THERE IS NO REINTERVENTION PLANNED AT THIS TIME.

    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 10548584

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other PROTONIX| METOPROLOL| PATIENT MEDICATIONS: DUONEB,