BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24855147 · Received April 13, 2026

    Report

    Report Number
    2017233-2026-07362
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 13, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132645633
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL 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.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B ACUTE AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM(CTAG/AC). AFTER DEPLOYING THE FIRST CTAG/AC DEVICE, IT WAS OBSERVED THE DEVICE MIGRATED DISTALLY; THEREFORE, THE 2ND CTAG/AC DEVICE WAS DEPLOYED PROXIMALLY. REPORTEDLY, THE PROXIMAL SIDE OF THE DEVICE DID NOT APPEAR TO BE FULLY EXPANDED. AFTER REMOVING ALL DEPLOYMENT LINES, AN ATTEMPT WAS MADE TO WITHDRAW THE DELIVERY CATHETER, BUT THE STENT GRAFT WAS OBSERVED TO MOVE TOGETHER WITH IT. A BALLOON WAS ADVANCED FROM THE CONTRALATERAL SIDE AND INFLATED NEAR THE OLIVE TIP, WHICH APPEARED TO EXPAND THE PROXIMAL SIDE OF THE STENT GRAFT; HOWEVER, ONCE THE BALLOON WAS DEFLATED, THE PROXIMAL SIDE OF THE DEVICE WAS ALSO RETURNED TO ITS PREVIOUS SHAPE. WHEN THE DELIVERY CATHETER WAS PUSHED FORWARD, THE OBSTRUCTION SEEMED TO RELEASE, ALLOWING THE PROXIMAL SIDE OF THE STENT GRAFT TO FULLY EXPAND, AND THE DELIVERY CATHETER WAS REMOVED WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916199 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132645633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown