BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 7709542 · Received July 22, 2018

    Report

    Report Number
    2017233-2018-00395
    Event Type
    Injury
    Date Received
    July 22, 2018
    Date of Event
    January 4, 2014
    Report Date
    June 29, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) ITEM NUMBER TGU343420 ALSO INVOLVED WITH THIS COMPLAINT. THE INFORMATION DESCRIBED IN THIS REPORT WAS COLLECTED BY THE SOCIETY OF VASCULAR SURGERY PATIENT SAFETY ORGANIZATION FOR THE VASCULAR QUALITY INITIATIVE (VQI). VQI DATA IS DOUBLE BLINDED, AND IS NOT MANAGED, MAINTAINED OR SUPERVISED BY GORE OR ANY REPRESENTATIVE OF GORE. NO ADDITIONAL INFORMATION RELATED TO THIS EVENT WILL BE MADE AVAILABLE TO GORE BY THE VQI. THEREFORE, FURTHER INVESTIGATION IS NOT POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE VIA THE VASCULAR QUALITY INITIATIVE (VQI) THAT ON AN UNKNOWN DATE IN 2014, A PATIENT UNDERWENT ELECTIVE ENDOVASCULAR TREATMENT OF AN ASYMPTOMATIC CHRONIC DISSECTION IN ZONE 3, WHICH EXTENDED TO ZONE 10. THE TEVAR INDICATION WAS PAIN. THE PRIMARY ENTRY TEAR WAS LOCATED IN ZONE 3 AND WAS COVERED. TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU343420 X2) WERE IMPLANTED WITHIN ZONES 3 AND 4 WITH COVERAGE EXTENDING FROM ZONE 3 TO 5. AT THE TIME OF THE INITIAL PROCEDURE, THE MAXIMUM AORTIC DIAMETER WAS REPORTED TO MEASURE 40MM, IN ZONE 5. BRANCH TREATMENT OF THE CELIAC ARTERY (CA), SUPERIOR MESENTERIC ARTERY (SMA), LEFT RENAL ARTERY (LRA) LEFT COMMON ILIAC ARTERY (LCIA), AND RIGHT COMMON ILIAC ARTERY (RCIA) WAS SUCCESSFULLY PERFORMED LEAVING ALL BRANCHES PATENT AND THE LSA UNCOVERED. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED COMPLICATIONS AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AREA AT DISCHARGE MEASURED 44MM. NO COMPLICATIONS WERE REPORTED AND ON UNKNOWN POST OPERATIVE DAY(S) POD 4 THE PATIENT WAS DISCHARGED TO HOME. THE PATIENT UNDERWENT FOLLOW UP VISITS ON UNKNOWN POST OPERATIVE DAY(S) POD(S): 53, 228, 599, 1197. ON AN UNKNOWN DATE, APPROXIMATELY POD 228, FOLLOW UP IMAGING REPORTED THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AORTA, EVG MEASURED 45MM. ON AN UNKNOWN DATE, APPROXIMATELY POD 599, FOLLOW UP IMAGING REPORTED THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AORTA, EVG MEASURED 53MM. ON AN UNKNOWN DATE, APPROXIMATELY POD 1197, FOLLOW UP IMAGING REPORTED THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AORTA, EVG MEASURED 33MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551480 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other