BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20755453 · Received November 22, 2024

    Report

    Report Number
    2017233-2024-05530
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 31, 2024
    Report Date
    February 18, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646821
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    H6: C19 -THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE RADIOGRAPHIC JPEG IMAGE RECEIVED FOR EVALUATION. NO DATE, NAME, OR DEMOGRAPHICS ON THE IMAGE. CANNOT MANIPULATE THE IMAGE IN ANY WAY. (WINDOW LEVELING, ROTATING, ETC.) IMAGE APPEARS TO SHOW A CONE SHAPED FOREIGN BODY PRESENT WITHIN A VESSEL (PROBABLE LEFT INTERNAL ILIAC ARTERY) OF THE PATIENT. THE FOREIGN BODY LIKELY REPRESENTS AN OLIVE FROM THE DELIVERY CATHETER PER THE DESCRIPTION SUMMARY. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE EVALUATION SHOWED THE FOLLOWING: THE FINDINGS OF THE EVALUATION ARE CONSISTENT WITH THE REPORTED EVENT DESCRIPTION THAT THE CURVED LEADING OLIVE WAS SEPARATED FROM THE CATHETER. BASED ON THE DEVICE EVALUATION, THE OLIVE WAS LIKELY NOT SUFFICIENTLY BONDED TO THE CATHETER. THE SEPARATION OF THE CURVED LEADING OLIVE FROM THE CATHETER IS LIKELY A MANUFACTURING DEFICIENCY RELATED TO THE CMDS OLIVE BONDING PROCESS. BASED ON THIS INVESTIGATION, THE POTENTIAL ROOT CAUSE IS INSUFFICIENT BRAIDED SHAFT DEPTH OR IMPROPER M2 MANDREL TOUCH OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH 37MM X 20CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG DEVICE) TO TREAT B THORACIC AORTIC DISSECTION. THE CTAG DEVICE WAS ADVANCED TO TARGET LESION VIA 22FR DSF SHEATH. THE STENT WAS SUCCESSFULLY EXPANDED. AFTER THE CATHETER WAS WITHDREW OUT OF PATIENT, IT WAS FOUND THE DISTAL OLIVE WAS DETACHED AND FELL INTO THE DEEP PART OF LEFT INTERNAL ILIAC ARTERY. IT COULDN'T BE REMOVED AND LEFT INSIDE OF PATIENT. THE PATIENT TOLERATED THE PROCEDURE AND NO FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580094 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132646821

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male