BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3873662 · Received June 16, 2014

    Report

    Report Number
    2017233-2014-00310
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    November 19, 2009
    Report Date
    May 26, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK, ANEURYSM EXPANSION, AND DEATH. ADDITIONALLY, USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT A SACCULAR ANEURYSM DEVELOPED AT THE DISTAL ANASTOMOTIC SITE OF A VASCULAR GRAFT IN THE DESCENDING THORACIC AORTIC ANEURYSM PLACED IN 2001. FINAL ANGIOGRAM SHOWED A SLIGHT TYPE 2 ENDOLEAK, BUT IT WAS LEFT TO BE MONITORED. THE PROCEDURE CONCLUDED. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 63 MM. ON (B)(6) 2009, THE PATIENT PRESENTED WITH THE ACCESS SITE DEHISCENCE. ON (B)(6) 2009, THE CLOSURE OF THE ACCESS SITE WAS PERFORMED. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED WITH THE PERSISTENT TYPE 2 ENDOLEAK. ON (B)(6) 2010, 3 MONTH FOLLOW UP IMAGES SHOWED THE PERSISTENT TYPE 2 ENDOLEAK. THE ANEURYSM DIAMETER MEASURED 67 MM. ON (B)(6) 2010, 6 MONTH FOLLOW UP IMAGES SHOWED THE PERSISTENT TYPE 2 ENDOLEAK. THE ANEURYSM DIAMETER MEASURED 69 MM. ON (B)(6) 2010, ONE YEAR FOLLOW UP IMAGES SHOWED THE PERSISTENT TYPE 2 ENDOLEAK. THE ANEURYSM DIAMETER MEASURED 70 MM. ON (B)(6) 2010, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL WITH A MASSIVE HEMATEMESIS DUE TO RUPTURED THORACIC ANEURYSM IN CARDIAC ARREST. THE PATIENT EXPIRED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352876 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7046300

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| O