BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3952615 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04706
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 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 CLIP DELIVERY SYSTEM (CDS) WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION NOTED SCRATCHES ON THE CDS HANDLE COUPLER; HOWEVER, THIS WAS LIKELY DUE TO THE TIGHTENING OF THE CDS FASTENER DURING OR AFTER THE PROCEDURE AND IS NOT AN INDICATION OF A PRODUCT ISSUE. DEVICE TESTING SHOWED THAT THE CLIP WAS ABLE TO BE OPENED TO 180 DEGREES AND THE LOCK LEVER WAS ABLE TO BE ADVANCED TO LOCK THE CLIP WITH NO ISSUES OBSERVED. NO RESISTANCE OR IRREGULAR MOVEMENT OF THE CLIP WAS OBSERVED. THUS, THE REPORTED DIFFICULT CDS HANDLE TRANSLATION, JUMPING/IRREGULAR MOVEMENT OF THE CLIP (DIFFICULT TO POSITION) AND DEVICE OPERATED DIFFERENTLY THAN EXPECTED COULD NOT BE CONFIRMED VIA RETURNED DEVICE TESTING. THE INNER COMPONENTS OF THE DEVICE WERE EXAMINED AND THE MANDREL WAS FOUND TO BE BENT. THERE WAS NO OTHER DAMAGE OBSERVED TO THE INNER COMPONENTS. IN THIS CASE, ALTHOUGH THE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTIES, THE DISCREPANCY BETWEEN WHAT WAS REPORTED AND WHAT WAS OBSERVED (NO IRREGULAR MOVEMENT OF THE CLIP OR DC) WAS LIKELY 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 (DUE TO THE ANATOMY, CURVES ON THE DEVICE) AND/OR INTERNAL DAMAGE (SUCH AS BENDS) MAY MAKE IT MORE DIFFICULT TO POSITION THE CLIP. POTENTIAL CAUSES FOR DIFFICULT DC HANDLE TRANSLATION, JUMPING/IRREGULAR MOVEMENT OF THE CLIP (DIFFICULT TO POSITION) AND DEVICE OPERATED DIFFERENTLY THAN EXPECTED ARE, BUT NOT LIMITED TO, PATIENT CONDITIONS SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, USER TECHNIQUE/PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING PREPARATION) OR 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 DISTAL TIP PROPERLY DEFLECTED AND THE CDS SHAFT/CLIP MET SPECIFICATION. THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS REPORTED FOR DIFFICULT CDS HANDLE TRANSLATION, JUMPING/IRREGULAR MOVEMENT OF THE CLIP (DIFFICULT TO POSITION) OR DEVICE OPERATED DIFFERENTLY THAN EXPECTED FROM THIS LOT. 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, DIFFICULT DC HANDLE TRANSLATION, JUMPING/IRREGULAR MOVEMENT OF THE CLIP (DIFFICULT TO POSITION) OR DEVICE OPERATED DIFFERENTLY THAN EXPECTED 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 ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED ISSUES, IT IS POSSIBLE THAT THERE WERE UNIDENTIFIED PROCEDURAL INTERACTIONS (PATIENT ANATOMY) WHICH RESULTED IN MORE TENSION ON THE DEVICE, SUCH THAT THE MANDREL BECAME BENT AND THEREFORE CONTRIBUTED TO THE REPORTED DIFFICULTIES; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO TURNS ON THE CDS HANDLE AND THE ALIGNMENT MARKERS WERE CONFIRMED TO BE ALIGNMENT. ANOTHER CDS WAS USED AND THE DEVICE WORKED AS EXPECTED. ONE CLIP WAS IMPLANTED REDUCING THE DEGENERATIVE MITRAL REGURGITATION GRADE FROM 4 TO 2. THERE WAS NO ADVERSE PATIENT EFFECT OR SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS THE CLIP WAS DIFFICULT TO POSITION WHILE IN THE LEFT VENTRICLE. ALTHOUGH THERE WAS NO ADVERSE PATIENT EFFECT, THIS EVENT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, THE CLIP DELIVERY SYSTEM (CDS) WAS PREPARED AND TESTED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DEVICE ISSUES NOTED. THE ANATOMY WAS NOT CHALLENGING. THE STEERABLE GUIDE CATHETER (SGC) STEERING KNOB WAS IN A NEUTRAL POSITION WHEN THE CDS WAS INSERTED AND THERE WAS NO RESISTANCE NOTED DURING THE INSERTION AND ADVANCEMENT OF THE CDS THROUGH THE SGC. AS PER THE IFU, THE CDS WAS NOT CURVED MORE THAN 90 DEGREES DURING PREPARATION OR PROCEDURE. DURING TRANSLATION OF THE DEVICE, THE CLIP DID NOT MOVE SLOWLY (STEP BY STEP), BUT THE CLIP JUMPED. AFTER ACHIEVING AN ACCEPTABLE CLIP POSITION, THE CLIP WAS MANEUVERED DOWN IN THE LEFT VENTRICLE AND THE CDS M STEERING KNOB WAS TURNED TO THE SIX O'CLOCK POSITION. THE CLIP WAS OPENED TO 180 DEGREES AND AFTER IT WAS RELOCKED, THE CLIP JUMPED TO THE MEDIAL COMMISSURE POSITION. THE POSITION WAS CORRECTED BY TURNING THE M KNOB TO THE FOUR O'CLOCK POSITION. THE CLIP WAS THEN RETRACTED BACK INTO THE LEFT ATRIUM. TENSION WAS FELT AND THE "FEELING" OF THE DEVICE WAS DIFFERENT THAN WHAT WAS EXPECTED. TRANSLATION OF THE DEVICE WAS PERFORMED SEVERAL TIMES IN ALL DIRECTIONS, BUT THE CLIP DID NOT MOVE AS EXPECTED. THE CLIP WOULD JUMP AND IT WAS NOT POSSIBLE TO BRING THE CLIP IN A STABLE PERPENDICULAR POSITION. AFTER APPROXIMATELY 20 MINUTES, THE DEVICE WAS REMOVED FROM THE ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431188 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10342835

    Patients

    Seq Age Sex Outcome Treatment
    1 MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER