BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5566590 · Received April 11, 2016

    Report

    Report Number
    2017233-2016-00340
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    February 7, 2012
    Report Date
    May 17, 2016
    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 MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT2810/8190780, TGT3420/8371887) TO REPAIR A THORACOABDOMINAL AORTIC ANEURYSM. BEFORE THE PROCEDURE, BYPASS FROM THE RIGHT COMMON ILIAC ARTERY TO THE CELIAC, SUPERIOR MESENTERIC AND BILATERAL RENAL ARTERIES WAS MADE TO MAINTAIN BLOOD FLOW BECAUSE THE PHYSICIAN PLANNED TO COVER THESE ARTERIES. THE ENDOPROSTHESES WERE IMPLANTED AND DISTAL END WAS LOCATED AT DISTAL OF INFERIOR MESENTERIC ARTERY AS PLANNED. AT THE END OF THE PROCEDURE, ARTERIAL HEMORRHAGE FROM THE EXTERNAL ABDOMINAL OBLIQUE MUSCLE AND RETROPERITONEAL HEMATOMA WERE FOUND. THE PHYSICIAN DECIDED TO CONCLUDE A PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, A HEMOSTATIC PROCEDURE (DETAIL UNKNOWN) WAS SUCCESSFULLY PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. A DIAMETER OF THE ANEURYSM WAS 35MM. ON (B)(6) 2011, SIX MONTH FOLLOW-UP IMAGING SHOWED NO ISSUES. ON (B)(6) 2012, ONE YEAR FOLLOW-UP IMAGING SHOWED NO ISSUES. A DIAMETER OF THE ANEURYSM WAS 39MM. ON (B)(6) 2012, TWO YEAR FOLLOW-UP IMAGING SHOWED THAT A DIAMETER OF THE ANEURYSM WAS ENLARGED TO 40MM. THERE WERE NO ENDOLEAKS AND OTHER COMPLICATIONS. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2013, THREE YEAR FOLLOW-UP IMAGING SHOWED THAT A DIAMETER OF THE ANEURYSM WAS ENLARGED TO 52MM. THERE WERE NO ENDOLEAKS AND OTHER COMPLICATIONS. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224347 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8190780

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other