BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2211223 · Received August 3, 2011

    Report

    Report Number
    2017233-2011-00396
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. IMAGES WERE SENT TO GORE FOR ANALYSIS AND SHOWED DISTAL LANDING ZONE DIAMETERS TO BE BETWEEN 27 - 28MM. ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE (B)(4) IS INTENDED FOR AORTIC DIAMETERS OF 29 - 32MM. FINAL PROCEDURAL ANGIOGRAPHY DID NOT HAVE ADEQUATE CONTRAST TO EVALUATE FOR AN ENDOLEAK. CTA IMAGES FROM (B)(6) 2011 AND (B)(6) 2011 POST REINTERVENTION SHOWED CONTRAST OUTSIDE OF THE DEVICE BUT THE ORIGIN OF THIS CONTRAST IS UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH THE GORE TAG THORACIC ENDOPROSTHESIS AND DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011, THE PT PRESENTED WITH AN ENDOLEAK AND ANOTHER GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED. NO OTHER SEQUELA HAS BEEN REPORTED.

    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 WLG426 8389611

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R