BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4914425 · Received July 14, 2015

    Report

    Report Number
    2017233-2015-00428
    Event Type
    Death
    Date Received
    July 14, 2015
    Date of Event
    August 31, 2010
    Report Date
    August 14, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE REVIEW OF THE STERILIZATION PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/7791985 AND TGT3415/7854224). ON (B)(6) 2010, TWO ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/ 7765409 AND TG3110/ 06234880) WERE IMPLANTED TO REPAIR A DISSECTION THAT DEVELOPED FROM THE DISTAL END OF THE TAG® DEVICE IMPLANTED ON (B)(6) 2010, TO AROUND THE COMMON ILIAC ARTERY. (THIS WAS REPORTED UNDER MFR REPORT #2017233-2010-00352) ON (B)(6) 2010, A GRAFT INFECTION WAS IDENTIFIED. THE PATIENT WAS TREATED WITH DRAINAGE AND ANTIBIOTICS. THE CAUSE OF THE INFECTION WAS NOT REPORTED TO GORE. ON AN UNKNOWN DATE, AN OPEN THORACIC SURGERY WAS PERFORMED, WHEREBY THE ASCENDING AORTA AND AORTIC ARCH WERE REPLACED WITH A VASCULAR GRAFT. IT IS UNKNOWN OF THE DEVICES WERE EXPLANTED. ON (B)(6) 2010, THE PATIENT EXPIRED DUE TO SEPSIS DEVELOPED FROM THE GRAFT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456681 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7791985

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death