BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 19907028 · Received August 5, 2024

    Report

    Report Number
    2017233-2024-05182
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 5, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132647002
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. IN ADDITION, THE DELIVERY CATHETER WAS DISCARDED. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE 2 DISSECTION WITH MALPERFUSION UTILIZING TBE AND TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAGAC). THE CTAGAC DEVICE WAS USED TO EXTEND DISTALLY TO THE CELIAC ARTERY FOR A TYPE B DISSECTION. UPON PRIMARY DEPLOYMENT OF THE CTAGAC DEVICE, ONLY HALF OF THE GRAFT WENT TO 50% DEPLOYMENT. THERE WAS ABOUT 10CM THAT DID NOT DEPLOY. PHYSICIAN THEN ATTEMPTED TO PULL THE SECONDARY HANDLE AND LOCK WIRE KNOB TO SEE IF ANY OF THOSE WORKED, AND SECONDARY HANDLE WOULD NOT DEPLOY THE DEVICE, AND LOCK WIRE WOULD NOT RELEASE THE GRAFT. THE BACK UP HATCH WAS OPENED, AND SINCE THE OTHER HANDLE AND LOCK WIRE KNOB WAS PULLED, THERE WAS NOT ENOUGH FIBERS AND WIRE TO PULL IN THE BACK UP HATCH. SINCE THIS WAS A TBE CASE, PHYSICIAN OBTAINED THE WIRE THAT WENT THROUGH THE ARM, AND PUT IT THROUGH THE PORTAL, AND INTO THE PARTIALLY DEPLOYED CTAGAC DEVICE. PHYSICIAN PUT A BALLOON INTO THE CTAGAAC DEVICE, AND BALLOONED IT, IN AN ATTEMPT TO BREAK THE STITCHING THAT WAS STILL CONSTRAINING THE CTAGAC DEVICE. THE CTAGAC DEVICE WAS EXPANDED TO FULL DIAMETER. PATIENT TOLERATED THE PROCEDURE AND THERE WERE NO PATIENT ADVERSE EVENTS. PHYSICIAN BELIEVES PATIENT'S HIGHLY TORTUOUS ANATOMY LED TO SOME DIFFICULTY IN THE PRIMARY DEPLOYMENT. PHYSICIAN PULLED THE DEPLOYMENT HANDLE WITH A LOT OF FORCE, AND PERHAPS THAT FORCE LED TO THE PRIMARY LINE DAMAGE. THE DELIVERY CATHETER WAS DISCARDED. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723350 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132647002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other