BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5144759 · Received October 13, 2015

    Report

    Report Number
    2017233-2015-00691
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    February 12, 2013
    Report Date
    October 12, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION UDIS: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT A SURGICAL PROCEDURE WHEREBY A BYPASS WAS ESTABLISHED FROM THE ASCENDING AORTA TO BRACHIOCEPHALIC, LEFT COMMON CAROTID, AND LEFT SUBCLAVIAN ARTERIES USING VASCULAR GRAFTS. ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING THEE GORE TAG THORACIC ENDOPROSTHESES (TGT2810/7606673, TGT3420/7783865, AND TGT4020/8081506) TO REPAIR A THORACIC AORTIC ANEURYSM. NO ISSUES WERE OBSERVED DURING THE PROCEDURE, AND THE PATIENT TOLERATED THE PROCEDURE. PRE-OPERATIVE ANEURYSM DIAMETER WAS NOT REPORTED. ON (B)(6) 2010, POST-OPERATIVE FOLLOW-UP IMAGING SHOWED NO ISSUES. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. SUBSEQUENT FOLLOW-UP IMAGING SHOWED NO ISSUES. THE ANEURYSM MEASURED 66MM; HOWEVER ON (B)(6) 2013, FOLLOW-UP IMAGING REVEALED A TYPE II ENDOLEAK OF UNKNOWN ORIGIN. THE ANEURYSM WAS MEASURED 67 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2014, FOLLOW-UP IMAGING SHOWED NO ENDOLEAK; HOWEVER THE ANEURYSM REPORTEDLY MEASURED 73 MM. THE CAUSE OF THE ANEURYSM ENLARGEMENT WAS REPORTEDLY UNKNOWN. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677350 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7606673

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other