BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17547416 · Received August 14, 2023

    Report

    Report Number
    2017233-2023-04202
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 21, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646852
    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: CODE D15 -ENGINEERING EVALUATION: THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE FULLY CONSTRAINED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE WAS RETURNED FOR EVALUATION. THE PRIMARY DEPLOYMENT LINE (PDL) WAS IDENTIFIED TO BE BROKEN NEAR THE PROXIMAL END OF THE DEVICE, ATTACHED TO THE STENT GRAFT AND SLEEVE. THE PRIMARY DEPLOYMENT LINE THAT REMAINED CONNECTED TO THE PRIMARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 103.5CM. THE OBSERVATIONS OF THE DEVICE EVALUATION SUPPORT THE PHYSICIAN¿S REPORT OF THE DEVICE NOT EXPANDING TO INTERMEDIATE DIAMETER FOLLOWING PRIMARY DEPLOYMENT. BASED ON THE LENGTH OF THE RETURNED SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB, THERE WAS NO INDICATION OF AN ISSUE WITH THE SDL. THE DEVICE LIKELY DID NOT EXPAND WHEN THE SDL WAS REMOVED DUE TO THE DEVICE REMAINING CONSTRAINED BY THE PRIMARY SLEEVE. THE OBSERVATIONS OF THE DEVICE EVALUATION SUPPORT THE PHYSICIAN¿S REPORT OF THE DEVICE NOT EXPANDING FOLLOWING SECONDARY DEPLOYMENT. THE CORE AND OUTER WRAP OF THE PDL FIBER APPEAR TO HAVE EXPERIENCED TENSILE FORCES AND ARE NOT INDICATIVE OF A CLEAN CUT. PRIMARY DEPLOYMENT NOT COMPLETING IS LIKELY DUE TO THE PRIMARY DEPLOYMENT LINE BREAKING. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES. THE CAUSE OF THE PRIMARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. D6: THE DEVICE WAS NOT IMPLANTED NOR EXPLANTED. H6 - INVESTIGATION FINDINGS: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. RETURNED DEVICE IS UNDER EVALUATION BY W. L. GORE & ASSOCIATES, INC. 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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TO BE IMPLANTED WITH A 40MM X 20CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS DEVICE) TO TREAT ANEURYSM AT AORTIC ARCH. CMDS DEVICE WAS PLANNED TO BE PLACED AT ASCENDING AORTA, AND "CHIMNEY" TECHNIQUE WAS USED TO RESERVE SOME BRANCHES OF THE ARCH. AFTER INSERTING THE DSF2233 SHEATH AND DELIVERING CMDS DEVICE TO TARGET LESION, PHYSICIAN PULLED THE FIRST DEPLOYMENT HANDLE. UNDER DSA FLUOROSCOPY, CMDS DEVICE WAS NOT EXPANDED. PHYSICIAN CONTINUED TO PULL THE SECOND DEPLOYMENT HANDLE, CMDS DEVICE WAS STILL NOT EXPANDED. NO ABNORMAL RESISTANCE WAS FELT WHEN PULLING THE DEPLOY HANDLE. PHYSICIAN CAREFULLY RETRACTED CMDS DEVICE INTO SHEATH AND REMOVED OUT OF BODY. ANOTHER CMDS DEVICE WAS USED AND WAS SUCCESSFULLY DEPLOYED. THE REMAINING PROCEDURE WAS COMPLETED ACCORDING TO THE PREOPERATIVE PLAN. THE PROCEDURE WAS SMOOTH, AND THE PATIENT'S CONDITION WAS STABLE AND WAS RETURNED TO THE WARD SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793692 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132646852

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female