BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 8761500 · Received July 3, 2019

    Report

    Report Number
    2017233-2019-00500
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    August 14, 2018
    Report Date
    July 5, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132618170
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. UPDATED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2018 A PATIENT WAS UNDERGOING TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION, ZONE 2 WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AS DISTAL EXTENSION TO AORTIC COMPONENT. THE MAXIMUM AORTIC DIAMETER IN THE TREATMENT ZONE WAS 44.6MM. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6), 2018 THE MAXIMUM AORTIC DIAMETER IN THE TREATED SEGMENT WAS 47MM. ON (B)(6), 2019 THE MAXIMUM AORTIC DIAMETER IN THE TREATED SEGMENT WAS 50.9MM ON (B)(6), 2019 DISTAL AORTIC FALSE LUMEN PERFUSION WAS NOTED. ON (B)(6), 2019 A REINTERVENTION TOOK PLACE WHEREBY THE DISTAL TREATMENT ZONE WAS EXTENDED WITH A ZENITH THORACIC ENDOVASCULAR GRAFT 38 X 1117MM (MODEL/CAT # G35357 / LOT # E3813611) MANUFACTURER: COOK-AORTIC. THE REINTERVENTION HAD A SUCCESSFUL OUTCOME.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM ENLARGEMENTS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION, ZONE 2 WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AS DISTAL EXTENSION TO AORTIC COMPONENT. THE MAXIMUM AORTIC DIAMETER IN THE TREATMENT ZONE WAS 44.6MM. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2018 THE MAXIMUM AORTIC DIAMETER IN THE TREATED SEGMENT WAS 47MM. ON (B)(6) 2019 THE MAXIMUM AORTIC DIAMETER IN THE TREATED SEGMENT WAS 50.9MM. ON (B)(6) 2019 DISTAL AORTIC FALSE LUMEN PERFUSION WAS NOTED. ON (B)(6) 2019 A REINTERVENTION TOOK PLACE WHEREBY THE DISTAL TREATMENT ZONE WAS EXTENDED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554861 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 17764518 00733132618170

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R