BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 9324239 · Received November 14, 2019

    Report

    Report Number
    2017233-2019-01143
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 18, 2019
    Report Date
    December 11, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    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

    THE DEVICE WAS RETURNED TO GORE FOR EVALUATION. THE ENGINEERING INVESTIGATION REVEALED THERE WAS EXCESS RESISTANCE/DIFFICULTY WHEN TRACKING THE DEVICE OVER A LUNDERQUIST GUIDEWIRE AND THE GUIDEWIRE WAS UNABLE TO BE ADVANCED PAST THE OLIVE. THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 110.65CM, WHICH IS SHORTER THAN THE EXPECTED LENGTH FROM A FULLY DEPLOYED SECONDARY SLEEVE. THE CORE OF THE FIBER WHERE THE FAILURE OCCURRED APPEARS TO HAVE EXPERIENCED TENSILE FORCES AND THE FIBER AT THE BREAKAGE IS NOT INDICATIVE OF A CLEAN CUT. THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE HAVING BROKEN BEFORE DEPLOYMENT WAS COMPLETE, SUPPORTING THE PHYSICIAN¿S OBSERVATION THAT THE DEVICE WAS NOT FULLY EXPANDED FOLLOWING REMOVAL OF THE SDL. THE ROOT CAUSE FOR RESISTANCE AND DIFFICULTY WHEN ADVANCING THE DEVICE ON THE GUIDEWIRE PAST THE LEADING OLIVE CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE FOR SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING AT THE TRAILING END OF THE DEVICE. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES, WITH SOME SIGNS OF POTENTIAL DAMAGE TO THE OUTER WRAP. THE ROOT CAUSE FOR THE SECONDARY DEPLOYMENT LINE BREAK COULD NOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT REQUESTED, BUT NOT PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: ITEM #TGM343415J, LOT #: 20507067, UDI #(B)(4) WHICH IS CAPTURED IN MANUFACTURER REPORT #2017233-2019-01142.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE. ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG-AC). AN ULTRA STIFF GUIDEWIRE WAS INSERTED INTO THE PATIENT FROM THE LEFT COMMON FEMORAL ARTERY AND A 22FR GORE® DRYSEAL FLEX SHEATH WAS ADVANCED OVER THE GUIDEWIRE. THEN THE FIRST CTAG-AC (TGM343415J/20507067) WAS ALSO ADVANCED OVER THE GUIDEWIRE. DURING THE FIRST CTAG-AC ADVANCEMENT, THE GUIDEWIRE WAS CAUGHT BY THE FIRST CTAG-AC AND AN UNUSUALLY STRONG RESISTANCE WAS ENCOUNTERED. DUE TO THIS, THE GUIDEWIRE WAS UNINTENTIONALLY MOVED INTO A LEFT VENTRICLE AND PREMATURE VENTICULAR CONTRACTION WAS CAUSED SEVERAL TIMES. EVENTUALLY, THE FIRST CTAG-AC WAS PLACED IN THE INTENDED POSITION ALTHOUGH IT TOOK TIME. WHEN THE DELIVERY SYSTEM OF THE FIRST CTAG-AC WAS REMOVED, THE STRONG RESISTANCE WAS ALSO MET AND THE GUIDEWIRE WAS UNINTENTIONALLY REMOVED WITH THE FIRST CTAG-AC. THE PHYSICIAN THOUGHT THE GUIDEWIRE MIGHT HAVE PROBLEMS WITH THE COATING. THEREFORE, THE GUIDEWIRE WAS REPLACED WITH ANOTHER ONE (SUPER STIFF GUIDEWIRE). THEN THE SECOND CTAG-AC (TGMR404010J/2042847) WAS INSERTED OVER THE GUIDEWIRE. HOWEVER, THE SAME RESISTANCE WAS ENCOUNTERED. THE SECOND CTAG-AC WAS SOMEHOW ADVANCED IN THE TARGET POSITION. THE PRIMARY DEPLOYMENT LINE WAS REMOVED AND THEN THE SECONDARY DEPLOYMENT LINE WAS REMOVED WITHOUT ANGULATION CONTROL. DURING REMOVAL OF THE SECONDARY DEPLOYMENT LINE, A RESISTANCE WAS ENCOUNTERED. WHEN THE SECONDARY DEPLOYMENT LINE WAS REMOVED, THE LINE BECAME SEPARATED. THE DEPLOYMENT LINE ACCESS HATCH WAS OPENED BUT THERE WAS NO SECONDARY LINE THERE. ANGIOGRAPHY REVEALED THAT THE SECOND CTAG-AC WAS NOT FULLY EXPANDED. IT WAS CONSIDERED TO HAVE BALLOONING VIA THE LEFT COMMON FEMORAL ARTERY AFTER REMOVAL OF THE LOCKWIRE AND ANGULATION FIBERS. HOWEVER, IT COULD POSSIBLY RESULT IN THE SECOND CTAG-AC MOVEMENT DISTALLY. THEREFORE, THE RIGHT COMMON FEMORAL ARTERY WAS INCISED AND A BALLOON WAS INSERTED FROM THE RIGHT COMMON FEMORAL ARTERY AFTER A 20FR GORE® DRYSEAL FLEX SHEATH WAS INSERTED. THE SECOND CTAG-AC WAS FULLY EXPANDED WITH THE BALLOONING. THE PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE. THE GUIDEWIRE WILL BE RETURNED TO GORE WITH CTAG-AC FOR EVALUATION. PLEASE INVESTIGATE THE CAUSE OF STRONG RESISTANCE USING THE GUIDEWIRE. IT IS ALSO REQUIRED TO INVESTIGATE THE CAUSE OF DEPLOYMENT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116476 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20424847

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR