BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3882169 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03918
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 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). EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND THE ANALYSIS OF THE RETURNED CLIP DELIVERY SYSTEM (CDS) WERE REVIEWED. AN ATTEMPT WAS MADE TO OPEN THE CLIP ON BENCH WITH NO CURVES APPLIED AND THE CLIP FAILED TO OPEN UPON FIRST ATTEMPT. TO SIMULATE A CLINICAL CONDITION, THE CDS AND A PROXY STEERABLE GUIDING CATHETER (SGC) WERE INSERTED INTO A WATER BATH WITH A SIMULATED INFERIOR VENA CAVA. WITH THE DC SHAFT EXTENDED APPROXIMATELY 1CM, A CURVE OF 75 DEGREES WAS APPLIED TO THE SGC IN THE + DIRECTION AND 90 DEGREES WAS APPLIED TO THE CDS STEERABLE SLEEVE IN THE M DIRECTION. ANOTHER ATTEMPT WAS MADE TO OPEN THE CLIP, BUT IT FAILED TO OPEN. TROUBLESHOOTING MANEUVERS WERE PERFORMED TWICE BY PULLING THE LOCK LEVER UP TO 10MM PASSED THE BLUE LINE AND THE CLIP WAS UNABLE TO BE OPENED. THE ARM POSITIONER ALSO MET RESISTANCE WHILE TURNING IT TOWARD THE CLOSED DIRECTION AS THE CLIP WAS UNABLE TO BE OPENED. THE REPORTED CLIP DIFFICULT/UNABLE TO OPEN AND PHYSICAL RESISTANCE WITH THE ARM POSITIONER WERE CONFIRMED. THE DISCREPANCY BETWEEN WHAT WAS REPORTED (CLIP WOULD NOT OPEN FURTHER THAN 110 DEGREES) AND WHAT WAS OBSERVED (THE CLIP FAILED TO OPEN) MAY BE DUE TO A COMBINATION OF VARYING AMOUNTS OF TENSION FELT BY THE DEVICE DURING THE PROCEDURE VERSUS THE RETURNED PRODUCT ANALYSIS AND INTERNAL DAMAGE TO THE ACTUATOR ASSEMBLY. MORE TENSION (E.G. CURVES ON THE DEVICE, DUE TO THE ANATOMY, ETC.) ON THE DEVICE AND INTERNAL DAMAGE (SUCH AS BENDS) MAY MAKE IT MORE DIFFICULT TO OPEN. IN AN EFFORT TO DETERMINE A CAUSE FOR THE FAILURE TO OPEN THE CLIP, THE CDS WAS REMOVED TO DEPLOY THE CLIP AND EXAMINE THE INNER COMPONENTS. ONCE THE LOCK LINE AND GRIPPER LINE WERE REMOVED, THE CLIP WAS OBSERVED TO BE LOOSE AND AFTER REMOVING THE RELEASE PIN AND ACTUATOR KNOB, THE ACTUATOR KNOB INNER ASSEMBLY WAS ABLE TO BE RETRACTED WITHOUT ROTATING IT 8 TIMES IN THE COUNTER CLOCKWISE DIRECTION. THIS IS CONSISTENT WITH THE ACTUATOR COUPLER BEING BROKEN, AS NOTED DURING THE ANALYSIS. THE DISTAL END OF THE BROKEN COUPLER WAS STILL SEATED ONTO THE THREADED STUD. DISCOLORATION WAS OBSERVED WITHIN THE CONNECTOR, ON THE L-LOCK ASSEMBLY AND ON THE ACTUATOR COUPLER. THERE WAS ALSO EVIDENCE OF SCRATCHING ON THE OUTER SURFACE OF THE COUPLER. THE ACTUATOR MANDREL WAS THEN REMOVED AND BENT APPROXIMATELY 12 DEGREES, 4.2CM PROXIMAL TO THE DISTAL END OF THE COUPLER. IN ORDER TO TEST THE FUNCTIONALITY OF THE CLIP, THE DISTAL END OF THE BROKEN ACTUATOR COUPLER WAS CAREFULLY UNTHREADED FROM THE THREADED STUD. THERE WAS NO DAMAGE OBSERVED TO THE THREADED STUD. THE CLIP WAS INSTALLED ON A PROXY SHORTY CATHETER CONTAINING A PROXY ACTUATOR COUPLER (THEREFORE STRAIGHT) TO SIMULATE ACTUATION OF THE CLIP; THE CLIP WAS FOUND TO OPEN AND INVERT SMOOTHLY. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY ISSUES OBSERVED DURING DEVICE PREPARATION, IT IS POSSIBLE THAT THE DISCOLORATION AND DAMAGE WERE A RESULT OF THE CONDITIONS THE DEVICE WAS SUBJECTED TO DURING AND/OR AFTER THE PROCEDURE. DURING DEVICE PREP/FUNCTIONAL INSPECTION AND USE, THE CLIP IS ACTUATED, WHERE MINOR SCRATCHING OF THE ACTUATOR COUPLER CAN OCCUR. ADDITIONALLY, THE DEVICE WAS USED ON (B)(6) 2014 AND THE RETURNED DEVICE EVALUATION WAS PERFORMED ON (B)(6) 2014. DURING THIS TIME, APPROXIMATELY 6 WEEKS PASSED FOR RETURN SHIPMENT AND REPORTED INFORMATION CLARIFICATION. THIS LAPSE IN TIME, AS WELL AS THE EXPOSURE TO FLUID/SALINE DURING TRANSIT, MAY HAVE EXACERBATED THE EFFECT OF THE SCRATCHING AND LIKELY CONTRIBUTED TO THE BREAK IN THE COUPLER WHILE ATTEMPTING TO DEPLOY THE CLIP DURING DEVICE TESTING. THE DISCOLORATION DOES NOT APPEAR TO BE RELATED TO THE REPORTED EVENT. POTENTIAL CAUSES FOR CLIP DIFFICULT TO OPEN CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY), USER TECHNIQUE, PROCEDURAL CONDITIONS (UNINTENDED CURVES ON THE DEVICE DURING ADVANCEMENT) OR MANUFACTURING ANOMALIES. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, DIFFICULTY OPENING THE CLIP MAY BE INFLUENCED PATIENT ANATOMICAL MORPHOLOGY AND PATIENT DISEASE STATE (SUCH AS TORTUOSITY OF THE VESSEL, RESULTING IN INCREASED TENSION ON THE DEVICE), UNINTENDED CURVES ON THE DEVICE DURING ADVANCEMENT OR EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER. IN THIS CASE, IT IS LIKELY THAT THE ACTUATOR ASSEMBLY (MANDREL AND/OR COUPLER) BECAME BENT DUE TO AN INTERACTION WITH THE GUIDE DURING CDS INSERTION, SUCH THAT THE CLIP COMPONENTS INTERFERED WITH ONE ANOTHER, RESULTING IN THE CLIP DIFFICULT TO OPEN. BASED ON THE INFORMATION REVIEWED, THE REPORTED CLIP DIFFICULT TO OPEN, PHYSICAL RESISTANCE WITH THE ARM POSITIONER AND NOTED DAMAGE (BENT MANDREL, SCRATCHING AND DISCOLORATION) APPEAR TO BE RELATED TO PROCEDURAL CONDITIONS/USER TECHNIQUE. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THE CLIP ITSELF. IT SHOULD BE NOTED THAT THE MITRACLIP INSTRUCTIONS FOR USE (IFU) STATES: TURN THE +/- KNOB TO NEUTRAL THEN CAREFULLY ADVANCE THE CDS THROUGH THE GUIDE UNDER FLUOROSCOPIC GUIDANCE. STOP WHEN THE CLIP JUST EXITS THE TIP OF THE GUIDE. IF RESISTANCE TO CDS ADVANCEMENT IS FELT, REDUCE GUIDE DEFLECTION. IN THIS CASE, IT IS LIKELY THAT THE CURVE ON THE GUIDE DURING CDS INSERTION CONTRIBUTED TO THE REPORTED BENDS IN THE ACTUATOR ASSEMBLY, WHICH RESULTED IN THE FAILURE TO OPEN THE CLIP. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT, AND A REVIEW OF THE COMPLAINT HISTORY FOR THIS LOT DID NOT INDICATE A SIMILAR ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION (CONTINUED): SUBSEQUENT PRELIMINARY ANALYSIS OF THE RETURNED DEVICE, DONE ON 05/28/2014, FOUND THAT THE ACTUATOR COUPLER WAS NOTED TO BE BROKEN. THE DISTAL END OF THE BROKEN PORTION WAS FULLY SEATED ONTO THE THREADED STUD. CONCOMITANT PRODUCTS: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THE BROKEN ACTUATOR COUPLER OF THE MITRACLIP CLIP DELIVERY SYSTEM (CDS) WHICH WAS FOUND DURING RETURNED DEVICE ANALYSIS AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO AN ADVERSE PATIENT EFFECT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS NOTED. CDS PASSED FUNCTIONAL TESTING PRIOR TO USE, AND WAS INSERTED AND ADVANCED WITHOUT ISSUE. IT WAS NOTED THAT THE PLUS KNOB WAS APPLIED TO THE STEERABLE GUIDING CATHETER (SGC) DURING INSERTION OF THE CDS, AND THE SGC TIP WAS NOT IN NEUTRAL PRIOR TO THE CDS EXITING THE SGC TIP. THE CDS WAS INTRODUCED INTO THE LEFT ATRIUM. THE CLIP WAS POSITIONED OVER THE MITRAL VALVE. THE CLIP WAS THEN OPENED TO CHECK THE PERPENDICULAR ALIGNMENT OVER THE VALVE, BUT IT WAS NOT POSSIBLE TO OPEN THE CLIP ARMS MORE THAN 110 DEGREES. THE CLIP WAS CLOSED AND THE LOCK LEVER WAS RETRACTED ABOUT 1 CM BEHIND THE BLUE LINE. ANOTHER ATTEMPT WAS MADE, BUT THE CLIP STOPPED AT THE DESCRIBED ARM ANGLE. THE CLIP COULD NOT BE OPENED TO 180 DEGREES. THE PHYSICIAN MENTIONED A STRONG RESISTANCE ON THE ARM POSITIONER WHEN THE CLIP REACHED THE ANGLE OF 110 DEGREES. THE SLEEVE OF THE CDS WAS NOT DEFLECTED MORE THAN 90 DEGREES AT ANY POINT IN THE PROCEDURE. IT WAS CONFIRMED THAT THIS ISSUE OCCURRED IN THE LEFT ATRIUM. THE CDS WAS REMOVED, AND A NEW CDS WAS USED TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO 1 WITH THE IMPLANTATION OF TWO CLIPS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358612 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10299455

    Patients

    Seq Age Sex Outcome Treatment
    1