BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1864770 · Received October 6, 2010

    Report

    Report Number
    2017233-2010-00438
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 5, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES RELATED TO THIS EVENT INCLUDE: TGT2810/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT UNDERWENT TREATMENT FOR REPAIR OF A PREVIOUSLY IMPLANTED STENT GRAFT (MANUFACTURER UNK) THAT WAS IMPLANTED TO TREAT A THORACIC AORTIC ANEURYSM. THE PT'S ANEURYSM HAD ENLARGED AND THE UNK STENT GRAFT APPEARED TO HAVE MELDED WITH THE PT'S LUNG. THE PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PT UNDERWENT A REINTERVENTION FOR ENLARGEMENT AND SPREADING OF THE ANEURYSM. THE AORTA WAS ANEURYSMAL BOTH PROXIMALLY AND DISTAL TO THE PREVIOUS IMPLANTED TAG DEVICES. TWO ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WERE PLACED TO EXTEND EXCLUSION OF THE ANEURYSM. THE PT TOLERATED THE PROCEDURE. THE AMOUNT OF ANEURYSM ENLARGEMENT IS UNK, THERE IS NO EVIDENCE OF AN ENDOLEAK.

    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 06812428

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention