BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3870746 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03783
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: ONCE OUTSIDE OF THE ANATOMY, WITH ALL STEERING KNOBS IN A NEUTRAL POSITION, THE CDS SLEEVE HAD A STRANGE CURVE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO SIGNIFICANT CLINICAL DELAY DUE TO THE DEVICE ISSUE. ANOTHER CDS AND SGC WERE USED. THE FUNCTIONAL MR GRADE WAS REDUCED FROM 4 TO 2. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS CONTINUED: MITRACLIP SYSTEM: LIFT, SUPPORT PLATE, STABILIZER, STEERABLE GUIDE CATHETER. THE CLIP DELIVERY SYSTEM IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - CDS WAS CURVED GREATER THAN 90 DEGREES. THE COMPLAINT DEVICE WAS RETURNED AND THE REPORTED DC SHAFT BEND WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE REPORTED DIFFICULT TO POSITION HOWEVER, WAS UNABLE TO BE CONFIRMED. THE SLEEVE KEY BOND WAS EXAMINED AND NOTED TO BE INTACT WITH EVIDENCE OF ADHESIVE AT THE PROXIMAL END OF THE KEY. THE KEY WAS IN THE CORRECT ORIENTATION ON THE STEERABLE SLEEVE. THE DC SHAFT WAS INSPECTED AND IDENTIFIED TO BE BENT. WITH THE DC (DELIVERY CATHETER) HANDLE FULLY ADVANCED AND SHAFT HELD TAUT, FUNCTIONAL INSPECTION OF THE CDS WAS PERFORMED BY ROTATING THE A/P (ANTERIOR/POSTERIOR) KNOB 3/4 OF A TURN IN EACH DIRECTION FROM NEUTRAL TO CONFIRM THE DISTAL TIP DEFLECTS PROPERLY. THIS WAS PERFORMED TWICE IN EACH DIRECTION AND THE TIP DEFLECTED NORMALLY EACH TIME. THE M/L (MEDIO-LATERAL) KNOB WAS ALSO ROTATED TOWARD THE M DIRECTION TO CURVE THE SLEEVE TO 90 DEGREES. THIS WAS PERFORMED TWICE AND THE SLEEVE PROPERLY DEFLECTED EACH TIME WITHOUT ISSUE. EVALUATION SUMMARY: TESTING FOR THE REPORTED DIFFICULTY POSITIONING (SLEEVE STEERING) AND DC SHAFT BEND WAS PERFORMED BY INSERTING THE RETURNED CDS AND A PROXY SGC INTO A 37 DEGREE WATER BATH WITH A SIMULATED INFERIOR VENA CAVA TO SIMULATE THE CLINICAL CONDITION. WITH THE DC SHAFT FULLY EXTENDED, A CURVE OF 75 DEGREES WAS APPLIED TO THE SGC IN THE PLUS (+) DIRECTION AND A 90 DEGREE CURVE WAS APPLIED TO THE CDS STEERABLE SLEEVE IN THE M DIRECTION. THE DEVICE FUNCTIONED AS EXPECTED AS THE STEERABLE SLEEVE CURVED/DEFLECTED PROPERLY IN THE MEDIAL DIRECTION WHEN APPLYING THE M CURVE. SINCE THE CLIP WAS REPORTED TO DIVE MEDIAL UPON APPLYING THE P KNOB, THE P KNOB WAS APPLIED AND THE SLEEVE CURVED PROPERLY IN THE POSTERIOR DIRECTION, AND NOT IN MEDIAL DIRECTION AS REPORTED. IN AN ATTEMPT TO REPLICATE THE DC SHAFT BENDING, THE DC HANDLE WAS ROTATED AND TRANSLATED NEXT WITH THE DC SHAFT FULLY EXTENDED. THE DC SHAFT WAS OBSERVED TO BEND DURING ROTATION AND TRANSLATION OF THE HANDLE. THE CDS WAS REMOVED FROM THE SGC, AND UPON REMOVAL OF THE CDS FROM THE SGC, THE BLUE ALIGNMENT MARKERS WERE CONFIRMED TO BE ALIGNED. THE SLEEVE KEY WAS EXAMINED AGAIN AND THE KEY WAS CONFIRMED TO BE INTACT AND IN THE CORRECT ORIENTATION ON THE STEERABLE SLEEVE. THE REPORTED SLEEVE STEERING WAS UNABLE TO BE CONFIRMED. THE REPORTED BENDING OF THE DC SHAFT HOWEVER, WAS CONFIRMED. THE CLIP WAS DEPLOYED AND ACTUATOR MANDREL WAS REMOVED AND OBSERVED TO BE BENT APPROXIMATELY 44 DEGREES. SCRATCHES WERE OBSERVED ON THE ACTUATOR COUPLER. THERE WAS NO OTHER DAMAGE NOTED TO THE INTERNAL COMPONENTS. EVEN THOUGH THE REPORTED DIFFICULTY POSITIONING THE CDS (CLIP MOVEMENT TOWARDS MEDIAL DIRECTION) WAS NOT CONFIRMED, THE BENDING/CURVING OF THE DC SHAFT WAS CONFIRMED, AND THE DISCREPANCY REGARDING WHAT WAS REPORTED (SLEEVE STEERING), AND WHAT WAS OBSERVED (NO ISSUES WITH THE SLEEVE STEERING) MAY HAVE BEEN DUE TO VARYING AMOUNTS OF TENSION FELT BY THE DEVICE DURING THE PROCEDURE VERSUS THE RETURNED PRODUCT ANALYSIS. MORE TENSION ON THE DEVICE FROM THE CURVES ON THE DEVICE, DUE TO THE ANATOMY, OR THE BENT DC SHAFT, CAN RESULT IN THE REPORTED DIFFICULTY. POTENTIAL CAUSES FOR DIFFICULTY POSITIONING THE CDS AND BENDING/CURVING OF THE DC SHAFT CAN BE CAUSED BY, BUT ARE NOT LIMITED TO, MANUFACTURING ANOMALIES, PATIENT CONDITIONS SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, USER TECHNIQUE OR PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING THE PROCEDURE). WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, SLEEVE STEERING ISSUES AND DC SHAFT BENDS 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. IT SHOULD BE NOTED THAT THE MITRACLIP INSTRUCTION FOR USE (IFU) CAUTIONS, DO NOT DEFLECT THE SLEEVE MORE THAN 90 DEGREES OF TIP DEFLECTION WITH THE SLEEVE KNOBS. IN THIS CASE, IT IS LIKELY THAT A COMBINATION OF THE PATIENT ANATOMY, RESULTING IN THE TRANSSEPTAL PUNCTURE BEING TOO HIGH SUCH THAT THE USER HAD TO DEFLECT THE SLEEVE MORE THAN 90 DEGREES DURING THE PROCEDURE, CONTRIBUTED TO THE BENT DC SHAFT AND MANDREL, RESULTING IN DIFFICULTY POSITIONING THE CDS, SCRATCHING OF THE COUPLER, FAILURE TO ADVANCE AND DIFFICULTY GRASPING THE LEAFLETS. THEREFORE, BASED ON THE INFORMATION REVIEWED, THE REPORTED SLEEVE STEERING, DC SHAFT BEND, FAILURE TO ADVANCE, DIFFICULTY GRASPING THE LEAFLETS, AND THE OBSERVED BENT MANDREL AND SCRATCHED COUPLER APPEAR TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS/USER TECHNIQUE AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT FOUND NO SIMILAR INCIDENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS REPORT IS FILED AS THE CLIP DELIVERY SYSTEM (CDS) SHAFT WAS CURVED AND THE DEVICE TO MOVED MEDIALLY WHILE IN THE LEFT VENTRICLE. ALTHOUGH THERE WAS NO ADVERSE PATIENT EFFECT, THE CURVING AND MEDIAL MOVEMENT HAVE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE THE CDS AND STEERABLE GUIDE CATHETER (SGC) WERE PREPARED FOR USE AS PER THE INSTRUCTIONS FOR USE (IFU). THE TRANSSEPTAL PUNCTURE WAS PERFORMED AS PER THE IFU, BUT DUE TO A LARGE LEFT ATRIUM, THE PUNCTURE WAS HIGH MEASURING 4.3CM ABOVE THE MITRAL VALVE. THE CLIP WAS THEN POSITIONED ABOVE THE MITRAL REGURGITATION (MR) JET AS PER THE IFU, BUT WHEN THE CDS HANDLE WAS MAXIMALLY ADVANCED, THE CLIP WAS STILL ABOVE THE ANTERIOR LEAFLET. THE CLIP WAS RETRACTED AND THE SGC STEERING PLUS KNOB WAS MAXIMALLY APPLIED WHICH MOVED THE CLIP FURTHER FROM THE VALVE. THE SGC STEERING NEGATIVE KNOB WAS USED WHICH IMPROVED THE CLIP POSITION, BUT THE CLIP STILL COULD NOT BE SUCCESSFULLY ADVANCED INTO THE LEFT VENTRICLE AS THE DEVICE WAS DIVING MEDIALLY. WHEN THE CDS STEERING POSTERIOR (P) KNOB WAS TURNED THE CLIP DIVED DRAMATICALLY IN THE MEDIAL DIRECTION AND THE CDS CURVE WAS MORE THAN 90 DEGREES. THE CLIP COULD NOT BE PLACED IN THE MR JET (NO CDS M KNOB AND SGC WAS MAXIMALLY RETRACTED). DUE TO THE CURVING OF THE DEVICE AND THE ANGLE OF THE CLIP, IT WAS IMPOSSIBLE TO GRASP THE LEAFLETS WITH THE CLIP. THE CDS AND SGC WERE REMOVED AND A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEIGHT ABOVE THE VALVE OF 3.8CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347987 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10321575

    Patients

    Seq Age Sex Outcome Treatment
    1