BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3870742 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03779
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 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). EVENT DESCRIPTION (CONTINUED): THE SLEEVE OF THE CDS WAS NOT DEFLECTED MORE THAN 90 DEGREES AT ANY POINT AND THERE WERE NO TURNS ON THE DC HANDLE. THE CDS WAS REMOVED WITH THE CLIP AND A NEW CDS WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE MR GRADE WAS REDUCED TO 1-2 WITH THE IMPLANTATION OF TWO CLIPS. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER, 1 IMPLANTED MITRACLIP. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 PRODUCT WERE REVIEWED. THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED CONSISTENT WITH PREPARATION OF THE DEVICE AND THE REPORTED USE. DURING FUNCTIONAL TESTING, THE DELIVERY CATHETER (DC) SHAFT WAS INSPECTED AND MET SPECIFICATION. AN ATTEMPT WAS MADE TO OPEN THE CLIP ON BENCH WITH NO CURVES APPLIED AND THE CLIP JUMPED OPEN TO 180 DEGREES WHEN TURNING THE ARM POSITIONER. TO SIMULATE A CLINICAL CONDITION, THE RETURNED CDS AND A PROXY STEERABLE GUIDE CATHETER (SGC) WERE INSERTED INTO A WATER BATH WITH A SIMULATED INFERIOR VENA CAVA. A CURVE OF 75 DEGREES WAS APPLIED TO THE SGC IN THE + DIRECTION AND A CURVE OF 90 DEGREES WAS APPLIED TO THE STEERABLE SLEEVE IN THE M DIRECTION. ANOTHER ATTEMPT WAS MADE TO OPEN THE CLIP, BUT THE CLIP JUMPED OPEN TO 180 DEGREES. TROUBLESHOOTING MANEUVERS WERE PERFORMED TWICE BY PULLING THE LOCK LEVER UP TO 10MM PAST THE BLUE LINE AND THE CLIP SUBSEQUENTLY OPENED TO INVERT SMOOTHLY EACH TIME. THIS CONFIRMS THAT THE CLIP EXPERIENCED ACTUATION ISSUES UPON OPENING ATTEMPTS. HOWEVER, THE DISCREPANCY BETWEEN WHAT WAS REPORTED AND WHAT WAS OBSERVED 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 OR INTERNAL DAMAGE (SUCH AS BENDS) MAY MAKE IT MORE DIFFICULT TO OPEN THE CLIP AND/OR STEER THE DEVICE. IT WAS NOTED THAT DURING DEVICE TESTING, THE DC SHAFT WOULD BEND MORE MEDIAL WHILE OPENING THE CLIP TO INVERT, CONFIRMING THE REPORTED BENT DC SHAFT. IN AN EFFORT TO DETERMINE A CAUSE FOR THE REPORTED DIFFICULTIES, THE CDS WAS REMOVED TO DEPLOY THE CLIP AND EXAMINE THE INNER COMPONENTS. THE ACTUATOR MANDREL WAS BENT APPROXIMATELY 20 DEGREES, 4.7CM FROM THE DISTAL END OF THE COUPLER. THE HARNESS WAS ALSO NOTED TO BE BENT. HOWEVER, THE HARNESS LIKELY BENT DURING THE TROUBLESHOOTING MANEUVERS TO OPEN THE CLIP, AS RETRACTING THE LOCK LEVER BEYOND THE BLUE LINE WOULD PUT ADDITIONAL TENSION ON THE HARNESS DURING THESE ATTEMPTS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO THE REPORTED DIFFICULTIES. THERE WAS NO OTHER DAMAGE NOTED TO THE INTERNAL COMPONENTS. POTENTIAL CAUSES FOR DIFFICULTY OPENING THE CLIP AND DC SHAFT BENDS 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) AND MANUFACTURING ANOMALIES. AS PART OF THE MITRACLIP MANUFACTURING PROCESS, ALL DEVICES ARE SUBJECT TO VISUAL AND FUNCTIONAL INSPECTION TO VERIFY PRODUCT QUALITY. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP OPENED TO INVERT AND THE DC SHAFT MET SPECIFICATION. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT, AND A REVIEW OF THE COMPLAINT HISTORY DATABASE DID NOT INDICATE A MANUFACTURING ISSUE. THE USER ALSO REPORTED NO ISSUES WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, DIFFICULTY OPENING THE CLIP AND DC SHAFT BENDING MAY BE INFLUENCED BY 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, SINCE THE CLIP ACTUATED AS EXPECTED PRIOR TO USE AND THE ANALYSIS CONFIRMED THAT THE CLIP WAS ABLE TO INVERT SMOOTHLY USING A PROXY CATHETER, THE ISSUES OPENING THE CLIP AND BENDING OF THE DC SHAFT MAY HAVE BEEN ATTRIBUTED TO A COMBINATION OF THE BEND IN THE MANDREL AND TENSION ON THE DEVICE DURING THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, IT IS POSSIBLE THAT THERE WERE UNIDENTIFIED PROCEDURAL INTERACTIONS (E.G. PATIENT ANATOMY AND CURVES ON THE DEVICE) WHICH CAUSED MORE TENSION ON THE CDS, SUCH THAT THE MANDREL BECAME BENT AND THUS CONTRIBUTED TO THE DIFFICULTY OPENING THE CLIP AND SUBSEQUENT BENDING OF THE DC SHAFT; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE CLIP DELIVERY SYSTEM (CDS) PASSED FUNCTIONAL TESTING WITHOUT ISSUE. THE DELIVERY CATHETER (DC) SHAFT BEND AND THE CLIP JUMPING OCCURRED IN THE LEFT VENTRICLE (LV). THE TWO CLIP ARMS OPENED WITH A SLIGHT JUMP TO APPROXIMATELY 40 DEGREES IN THE LV. TROUBLESHOOTING STEPS WERE PERFORMED, WHICH INCLUDED PULLING THE LOCK LEVER FURTHER BEYOND THE BLUE LINE IN 5MM STEPS AND TURNING THE ARM POSITIONER IN THE CLOSED DIRECTION PRIOR TO OPENING THE CLIP. THE STORED TORQUE WAS RELEASED DURING POSITIONING, WITH NO TURNS ON THE DC HANDLE. THE SLEEVE OF THE CDS WAS NOT DEFLECTED MORE THAN 90 DEGREES, THERE WERE NO CURVES APPLIED TO THE STEERABLE GUIDING CATHETER (SGC), THE SGC TIP WAS IN NEUTRAL PRIOR TO THE CDS EXITING, THERE WAS NO RESISTANCE NOTED DURING INSERTION OR ADVANCEMENT OF THE CDS THROUGH THE SGC OR THE ANATOMY, AND NO CHALLENGING ANATOMICAL CONDITIONS NOTED.

    Description of Event or Problem · 1

    THIS IS BEING SUBMITTED TO REPORT THE JUMPING OF THE CLIP (10328595/04) WHILE OPENING IN LEFT VENTRICLE. THIS HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3, WITH A JET IN THE MEDIAL PART OF THE A2/P2 REGION OF THE LEAFLETS. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS NOTED. THE FIRST CLIP WAS PLACED WITHOUT INCIDENT. DUE TO A REMAINING JET LATERAL OF THE FIRST CLIP THE DECISION WAS MADE TO IMPLANT A SECOND CLIP (10328595/04). THE CLIP DELIVERY SYSTEM (CDS) PASSED ALL TESTING ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CDS WAS INSERTED AND ADVANCED THROUGH THE STEERABLE GUIDING CATHETER (SGC) WITHOUT ISSUE. THERE WERE NO CURVES APPLIED TO THE SGC DURING INSERTION OF THE CDS, AND THE SGC TIP WAS IN NEUTRAL PRIOR TO THE CDS EXITING THE SGC. THE CLIP WAS ORIENTED IN LEFT ATRIUM (LA). WHILE OPENING THE CLIP IN THE LEFT VENTRICLE (LV), THE DELIVERY CATHETER (DC) SHAFT BECAME BENT 10 DEGREES. THE CLIP ARMS OPENED WITH A SLIGHT JUMP TO APPROXIMATELY 40 DEGREES. THE PHYSICIAN DECIDED TO CONTINUE USE WITH THE CDS AND ADVANCED THE CLIP FURTHER INTO THE LV; HOWEVER, THEN THE CLIP COULD NOT OPEN. A BENDING UNDER FLUOROSCOPY WAS OBSERVED BUT THE CLIP DID NOT OPEN. THERE WERE NO KNOBS USED. THE M- KNOB WAS IN THE 5 OCLOCK POSITION. THE LOCK LEVER WAS PULLED FURTHER BEYOND THE BLUE LINE IN 5MM STEPS AND THE ARM POSITIONER TURNED IN THE CLOSED DIRECTION BUT THE CLIP DID NOT OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348394 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10328595

    Patients

    Seq Age Sex Outcome Treatment
    1