BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 11374481 · Received February 24, 2021

    Report

    Report Number
    2017233-2021-01704
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 29, 2021
    Report Date
    June 7, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS: CODE 3252 - THE DEVICE WAS RETURNED AND AN ENGINEERING EVALUATION WAS PERFORMED. THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 123.4 CM. THIS IS SIGNIFICANTLY SHORTER THAN THE APPROXIMATE 145 CM SDL ATTACHED TO THE DEPLOYMENT KNOB OF A FULLY DEPLOYED SECONDARY SLEEVE ON A SEPARATE 31X31X10 DEVICE. THE CORE AND OUTERWRAP OF THE FIBER APPEAR TO HAVE EXPERIENCED TENSILE FORCES AND ARE NOT INDICATIVE OF A CLEAN CUT. THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE BREAKING, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE REMAINING AT INTERMEDIATE DIAMETER FOLLOWING INCOMPLETE SECONDARY DEPLOYMENT. SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES. THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS OR COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO, INCOMPLETE STENT GRAFT DEPLOYMENT AND DEPLOYMENT DIFFICULTIES/FAILURES. H.6. INVESTIGATION FINDINGS: CODE 3233 UPDATED TO CODE 3252. H.6. INVESTIGATION CONCLUSIONS: CODE 11 UPDATED TO CODE 4315

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: ASKED BUT UNAVAILABLE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DISTAL STENT GRAFT-INDUCED NEW ENTRY (DSINE) USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE FIRST CTAG/AC DEVICE (TGMR313120J) WAS PLACED WITH NO REPORTED ISSUES. THE SECOND CTAG/AC DEVICE (TGMR313110J) WAS DEPLOYED DISTALLY. IT WAS REPORTED THAT THE PRIMARY DEPLOYMENT LINE WAS REMOVED AND THE DEVICE WAS DEPLOYED TO THE INTERMEDIATE DIAMETER. AS THE PHYSICIAN BEGAN TO PULL THE SECONDARY DEPLOYMENT LINE IN ORDER TO DEPLOY THE DEVICE FULLY, A STRONG RESISTANCE WAS REPORTED AFTER PULLING THE DEPLOYMENT LINE APPROXIMATELY 20CM. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO PULL THE DEPLOYMENT LINE ANY FURTHER. INTRA-OPERATIVE IMAGING REPORTEDLY REVEALED THAT THE DEVICE REMAINED AT THE INTERMEDIATE DIAMETER. THE PHYSICIAN ATTEMPTED TO MANIPULATE THE ANGULATION DIAL TO PULL THE DEPLOYMENT LINE, BUT THE ATTEMPT WAS UNSUCCESSFUL. ANOTHER ATTEMPT WAS MADE AND THE RED LOCK WIRE HANDLE AND ANGULATION CONTROL HANDLE WERE REMOVED. THE PHYSICIAN REPORTEDLY PULLED THE SECONDARY DEPLOYMENT LINE AGAIN, BUT STRONG RESISTANCE WAS FELT. IT WAS REPORTED THAT THE SECONDARY DEPLOYMENT LINE EVENTUALLY BROKE. THE DELIVERY CATHETER WAS REMOVED. THE CTAG A/C DEVICE WAS FULLY DEPLOYED FROM DISTAL END TO PROXIMAL END USING A GORE® TRI-LOBE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271955 GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR