BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4182346 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06784
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED TO THE LOOSE BOND BETWEEN THE KEY AND SLEEVE SHAFT WAS IDENTIFIED AND IS BEING ADDRESSED. IT WAS DETERMINED THAT A LOOSE BOND BETWEEN THE KEY AND THE SLEEVE SHAFT WAS RESULTING IN CDS STEERING ISSUES. THE KEY IS BONDED TO THE SLEEVE SHAFT USING ADHESIVE. IT WAS DETERMINED THAT UNINTENDED HEATING OF THE BOND AREA DURING SECONDARY PROCESSING COULD RESULT IN A LOW RATE OF INCIDENCE OF INSUFFICIENT BONDING BETWEEN THE KEY AND THE SLEEVE SHAFT. THE FOLLOWING CORRECTIVE ACTIONS WERE TAKEN: (1) THE MANUFACTURING DOCUMENTATION WAS UPDATED TO CLARIFY THE DESIRED AREA OF APPLICATION OF HEAT DURING THE SECONDARY PROCESSING STEP TO AVOID UNNECESSARY HEATING OF THE KEY BOND AREA (2) AWARENESS TRAINING WAS ROLLED OUT TO PRODUCTION PERSONNEL ON THE FAILURE MODE AND POTENTIAL IMPLICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4) EVENT DESCRIPTION CONTINUED: REPORTEDLY, THE PATIENT EXPERIENCES SHORTNESS OF BREATH (SOB), WITHOUT TREATMENT, SINCE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE THIRD CLIP DELIVERY SYSTEM (40609U407) REFERENCED IS BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE FIRST STEERABLE GUIDING CATHETER (40717U112) REFERENCED IS BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    THIS MITRACLIP REPORT IS BEING FILED AS THE CLIP (40717U322) WAS DIFFICULT TO REMOVE FROM THE STEERABLE GUIDE CATHETER. IT WAS REPORTED THAT THE FIRST CLIP DELIVERY SYSTEM (CDS) (40717U322) WAS INSERTED AND ADVANCED THROUGH THE NEUTRAL STEERABLE GUIDE CATHETER (SGC) (40717U112), WITHOUT RESISTANCE, IN A PATIENT WITH DEGENERATIVE MITRAL REGURGITATION (MR) OF 4. THE DEVICE WAS IN THE LEFT ATRIUM AND UPON M KNOB APPLICATION, THE DEVICE DEFLECTED TOWARDS THE PULMONARY VEIN. NO GRASPING WAS ATTEMPTED AND NO TISSUE DAMAGE WAS NOTED. DURING CDS REMOVAL, THE CLIP CAUGHT THE SIDE OF THE SGC TIP. CAREFUL PRESSURE WAS APPLIED TO THE CLIP TO MOVE IT FORWARD OFF THE SGC TIP. THE PHYSICIAN SUSPECTED SGC TIP DAMAGE SO BOTH THE CDS AND THE SGC WERE REMOVED SEPARATELY. SOFT TIP TEAR WAS NOTED, ON THE SGC, ONCE REMOVED. THERE WAS NO REPORTED EMBOLIZATION. ANOTHER SGC WAS INSERTED AND ANOTHER CDS WAS SUCCESSFULLY ADVANCED AND THE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR TO 2. A THIRD CDS (40609U407) WAS ADVANCED AND PROPERLY STRADDLED. THE CLIP GRASPED THE LEAFLETS SUCCESSFULLY. UPON THE FINAL CLIP DEPLOYMENT, THE RELEASE PIN WAS NOT PULLED BACK ENOUGH AND THE RELEASE GROOVE WAS NOT FULLY EXPOSED. THE ENTIRE DC HANDLE WAS MOVED BACK, REMOVING THE CLIP FROM THE DELIVERY CATHETER AND FROM THE LEAFLETS, INTO THE LEFT ATRIUM. THERE WAS NO LEAFLET OR CARDIAC DAMAGE DUE TO THE CLIP DETACHMENT. USING THE GRIPPER LINES, THE CLIP WAS PULLED INTO THE INFERIOR VENA CAVA (IVC) AND THEN TO THE FEMORAL VEIN WHERE IT WAS SURGICALLY REMOVED. THE MR REMAINED AT 2 AND THE PATIENT IS IN STABLE CONDITION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: THE THIRD CLIP DELIVERY SYSTEM ((B)(4)) RELEASE PIN WAS REMOVED. THE ACTUATOR KNOB WAS ROTATED 8 TIMES COUNTERCLOCKWISE AND THE ACTUATOR KNOB WAS NOT FULLY RETRACTED TO RELEASE THE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661739 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40717U3

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR GUIDE CATH: STEERABLE GUIDING CATHETER