BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3854306 · Received June 6, 2014

    Report

    Report Number
    2024168-2014-03646
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FAILURE TO RELEASE STORED TORQUE DURING POSITIONING. THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED FOR ANALYSIS. VISUAL DEVICE INSPECTION FOUND THE CLIP INTRODUCER WAS DAMAGED (WRINKLED) ADJACENT TO THE HOUSING BOND. THIS WAS LIKELY DUE TO THE POST PROCEDURE HANDLING OF THE DEVICE UPON SEPARATING THE CDS FROM THE STEERABLE GUIDE CATHETER (SGC). THE ACTUATOR KNOB AND RELEASE CRIMPER (DEVICE COMPONENT LOCATED BELOW THE ACTUATOR KNOB) WERE NOTED TO BE LOOSE AS THE RELEASE CRIMPER COULD BE MANUALLY UNSCREWED FROM THE CRIMPING CAN. AFTER TESTING THE FUNCTIONALITY OF THE CLIP, THE REPORTED DIFFICULTY CLOSING THE CLIP AND PHYSICAL RESISTANCE ON THE ARM POSITIONER WERE CONFIRMED. THE RELEASE CRIMPER WAS MANUALLY TIGHTENED AND FURTHER TESTING WAS PERFORMED. THE CLIP WAS FUNCTIONALLY TESTED AGAIN AND THE CLIP WAS ABLE TO OPEN TO INVERT SMOOTHLY AND CLOSE WITHOUT ISSUE. A LOOSE RELEASE CRIMPER/CRIMPING CAM ASSEMBLY CAN POTENTIALLY CAUSE CLIP ACTUATION ISSUES (OPENING/CLOSING). ADDITIONAL INVESTIGATION IS BEING PERFORMED REGARDING THE CAUSE OF THE LOOSE RELEASE CRIMPER/CRIMPER CAM ASSEMBLY PER LOCAL QUALITY SYSTEM PROCEDURES. THE INVESTIGATION IDENTIFIED THE SLEEVE KEY LOOSE AND ABLE TO BE ROTATED AROUND THE STEERABLE SLEEVE. THE LOOSE SLEEVE KEY BOND WAS INVESTIGATED AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. IT WAS FURTHER REPORTED THAT THE STORED TORQUE WAS NOT RELEASED DURING POSITIONING. IT SHOULD BE NOTED THAT THE MITRACLIP INSTRUCTIONS FOR USE (IFU) STATES THAT A FAILURE TO FULLY RELEASE STORED TORQUE MAY RESULT IN UNWANTED CLIP ARM ORIENTATION CHANGES DURING GRASPING. IN THIS CASE, THIS DEVIATION IN THE IFU DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. EVALUATION SUMMARY: THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: LIFT, SUPPORT PLATE, STABILIZER, STEERABLE GUIDE CATHETER. THE CLIP DELIVERY SYSTEM IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER THE COMPLETE MITRACLIP SYSTEM WAS PULLED INTO THE GROIN AREA, THE CLIP WAS INVERTED AND PUSHED BACK INTO THE ILIAC VEIN AWAY FROM THE STEERABLE GUIDE CATHETER (SGC) TIP. WITH THE CLIP DELIVERY SYSTEM (CDS) STILL IN THE SGC, THE SGC WAS RETRACTED FROM THE ANATOMY AND THEN THE CDS WITH THE INVERTED CLIP WAS RETRACTED. THE CDS AND SGC WERE SEPARATED PRIOR TO PACKAGING FOR SHIPPING BACK TO ABBOTT FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS THE CLIP COULD NOT BE CLOSED AND WAS REMOVED FROM THE ANATOMY ON OPEN POSITION. ALTHOUGH THERE WAS NO ADVERSE PATIENT EFFECT, THE INABILITY TO CLOSE THE CLIP HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, THERE WAS NO RESISTANCE NOTED DURING THE INSERTION OR ADVANCEMENT OF THE CLIP DELIVERY SYSTEM (CDS) THROUGH THE STEERABLE GUIDE CATHETER (SGC). AS PER THE INSTRUCTIONS FOR USE, THERE WERE NO CURVES ON THE SGC DURING THE CDS INSERTION AND THE CDS WAS NOT CURVED MORE THAN 90 DEGREES DURING PREPARATION OR PROCEDURE. WHILE POSITIONING THE CLIP IN THE LEFT ATRIUM, THE CDS HANDLE WAS ROTATED APPROXIMATELY 20 DEGREES. THE STORED TORQUE WAS NOT RELEASED DURING POSITIONING. WHILE THE CLIP WAS GRASPING THE LEAFLET, NEAR THE FINAL TURNS OF THE ARM POSITIONER, RESISTANCE WAS FELT AND A HARD STOP OCCURRED. THE CLIP HAD NOT COMPLETELY CLOSED; IT WAS OPEN TO APPROXIMATELY 30 DEGREES. THE CLIP WAS ABLE TO BE INVERTED AND RETRACTED INTO THE LEFT ATRIUM. THE CLIP WAS ATTEMPTED TO BE CLOSED SEVERAL TIMES, BUT THE CLIP STOPPED CLOSING AT APPROXIMATELY 20-30 DEGREES EACH TIME AND THE ARM POSITIONER ALWAYS HAD A HARD STOP. IT WAS IMPOSSIBLE TO RETRACT THE CLIP INTO THE STEERABLE GUIDE CATHETER IN THE OPEN POSITION. THE CLIP WAS "ATTACHED" TO THE TIP OF THE SGC AND THE MITRACLIP SYSTEM WAS REMOVED FROM THE ANATOMY AS ONE UNIT. THERE WAS NO DAMAGE TO THE GROIN. THERE WAS NO ADVERSE PATIENT EFFECT. THE MITRACLIP PROCEDURE WAS ABORTED. THE PATIENT WILL UNDERGO ANOTHER MITRACLIP PROCEDURE IN APPROXIMATELY THREE WEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332989 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10328595

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR