BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3902750 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04221
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE CLIP DELIVERY SYSTEM WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP FUNCTIONED AS EXPECTED. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND REVIEW OF THE ELECTRONIC COMPLAINT HISTORY FOUND NO OTHER INCIDENTS HAVE BEEN REPORTED FROM THE REPORTED LOT. THE USER ALSO REPORTED NO ISSUES WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREP, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. POTENTIAL CAUSES FOR THE REPORTED SEPARATION / DETACHMENT OF THE ACTUATOR MANDREL RESULTING IN DIFFICULTY DEPLOYING THE CLIP CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING ANOMALIES, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY), USER TECHNIQUE OR PROCEDURAL CONDITIONS (UNINTENDED CURVES ON THE DEVICE DURING ADVANCEMENT). WITH RESPECT TO THE PATIENT CONDITION AND PROCEDURAL CONDITIONS, THE SEPARATION / DETACHMENT OF THE ACTUATOR MANDREL RESULTING IN DIFFICULTY DEPLOYING THE CLIP 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 OR USER TECHNIQUE (EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER, NOT RETRACTING THE ACTUATOR KNOB FAR ENOUGH, ETC). IN THIS CASE, SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE CAUSE OF THE SEPARATION OF THE ACTUATOR MANDREL RESULTING IN DIFFICULT TO DEPLOY COULD NOT BE CONFIRMED. SINCE THE CLIP WAS ABLE TO BE DEPLOYED FOLLOWING TROUBLESHOOTING MANEUVERS, IT IS POSSIBLE THAT THERE WERE PROCEDURAL INTERACTIONS (E.G. DUE TO THE ANATOMY) WHICH CAUSED MORE TENSION ON THE DEVICE AND CONTRIBUTED TO THE BREAK OF THE ACTUATOR MANDREL; HOWEVER, THIS CANNOT BE CONFIRMED. THE DIFFICULT TO DEPLOY THE CLIP WAS LIKELY A RESULT OF THE BREAK IN THE ACTUATOR MANDREL. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED BREAK OF THE COUPLER RESULTING IN DIFFICULT TO DEPLOY COULD NOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS DURING CLIP DEPLOYMENT AN INNER DEVICE COMPONENT, ACTUATOR MANDREL, BROKE AND WAS MANUALLY MANEUVERED DEPLOYING THE CLIP. THIS ACTION IS CONSIDERED MEDICAL INTERVENTION TO PREVENT INJURY. IT WAS REPORTED THAT PRIOR TO A MITRACLIP PROCEDURE, DURING FUNCTIONAL TESTING OF THE CLIP DELIVERY SYSTEM (CDS), THERE WERE NO DEVICE ISSUES OBSERVED. THERE WAS NO RESISTANCE DURING THE INSERTION OR ADVANCEMENT OF THE CDS THROUGH THE STEERABLE GUIDE CATHETER (SGC). AS PER THE INSTRUCTIONS FOR USE, THE CDS SLEEVE WAS NOT CURVED MORE THAN 90 DEGREES DURING PREPARATION OR PROCEDURE AND THERE WERE NO EXTREME CURVES PLACED ON THE SGC. THE PATIENT ANATOMY WAS NOT CONSIDERED AS CHALLENGING. THE STORED TORQUE WAS RELEASED DURING POSITIONING OF THE CLIP AND THE CDS HANDLE HAD BEEN TURNED A HALF A TURN DURING THE PROCEDURE. THERE WAS NO ABNORMAL RESISTANCE FELT WHILE TURNING THE ACTUATOR KNOB, BUT WHEN THE ACTUATOR KNOB WAS BEING PULLED TO RELEASE THE CLIP FROM THE CDS, THE ACTUATOR MANDREL BECAME STUCK AFTER 1/4 OF IT HAD BEEN RETRACTED, THE PHYSICIAN OPENED THE CDS HANDLE AND THE ACTUATOR MANDREL WAS FOUND TO BE BROKEN. THE PHYSICIAN MANUALLY MANEUVERED THE AXLE WHICH SUCCESSFULLY RELEASED THE CLIP FROM THE CDS AND THE CLIP WAS DEPLOYED. THE FUNCTIONAL MITRAL REGURGITATION GRADE WAS REDUCED FROM 3-4 TO 1. THERE WAS NO ADVERSE PATIENT EFFECT OR NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PATIENT WAS CLINICALLY STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379037 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10321645

    Patients

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