BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1401575 · Received June 11, 2009

    Report

    Report Number
    2017233-2009-00299
    Event Type
    Injury
    Date Received
    June 11, 2009
    Date of Event
    May 26, 2009
    Report Date
    June 10, 2009
    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

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN EARLY 2009, THE PATIENT WITH TRAUMATIC AORTIC TRANSACTION WAS TREATED WITH A GORE TAG THORACIC ENDOPROSTHESIS. THE FOLLOW-UP COMPUTED TOMOGRAPHY IMAGES REVEALED PROXIMAL DEVICE COMPRESSION AND TYPE I ENDOLEAK. FIVE MONTHS LATER, A REINTERVENTION OCCURRED WHERE THE PHYSICIAN PERFORMED ADDITIONAL BALLOONING. ALSO, THE PHYSICIAN IMPLANTED A PALMAX 4010 STENT AND A HAND-MADE STENT (BASED ON Z-STENT). A FINAL ANGIOGRAPHY SHOWED THAT THE COMPRESSION WAS RESOLVED AND THE ENDOLEAK COULD NO LONGER BE OBSERVED. THE PATIENT TOLERATED THE PROCEDURE.

    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 WLG326 06409301

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R