BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3001346 · Received March 6, 2013

    Report

    Report Number
    2017233-2013-00116
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    November 11, 2008
    Report Date
    February 22, 2013
    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 MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE CEREBRAL INFARCTS ARE UNK. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT UNDERWENT EMERGENT TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM AT THE ARCH WITH TWO GORE TAG THORACIC ENDOPROSTHESES. IT WAS REPORTED THAT A PLANNED BYPASS OF THE RIGHT COMMON CAROTID ARTERY, LEFT COMMON CAROTID ARTERY, LEFT COMMON CAROTID ARTERY, AND LEFT SUBCLAVIAN ARTERY WERE PERFORMED AS PART OF THE RUPTURE TREATMENT. ON (B)(6) 2008, THE PT EXPERIENCED A CEREBRAL INFARCT. IT WAS REPORTED THAT ALTHOUGH A CEREBROPROTECTIVE AGENT WAS ADMINISTERED, THE PT'S SYMPTOMS DID NOT IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95964 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 04965646

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| S