BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4182479 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06790
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. REPORTEDLY, THE PATIENT EXPERIENCES SHORTNESS OF BREATH (SOB), WITHOUT TREATMENT, SINCE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE - IMPROPER OR INCORRECT PROCEDURE OR METHOD. GROOVE WAS NOT CONFIRMED TO BE FULLY EXPOSED. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE FIRST CLIP DELIVERY SYSTEM AND THE FIRST STEERABLE GUIDING CATHETER REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: DUE TO THE CONDITION OF THE RETURNED DEVICE (NO CLIP RETURNED AND COUPLER STUCK INSIDE THE COMPRESSION COIL), THE REPORTED DIFFICULT TO DEPLOY THE CLIP COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. POTENTIAL CAUSES FOR INABILITY TO DEPLOY THE CLIP CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY) RESULTING IN ADDITIONAL TENSION ON THE DEVICE, USER TECHNIQUE/PROCEDURAL CONDITIONS (UNINTENDED CURVES ON THE DEVICE, FAILING TO RETRACT THE ACTUATOR KNOB UNTIL THE RELEASE PIN GROOVE IS FULLY EXPOSED, PREMATURELY RETRACTING THE DELIVERY CATHETER [DC] HANDLE) OR MANUFACTURING ANOMALIES. WITH RESPECT TO THE PATIENT CONDITIONS, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE INABILITY TO DEPLOY THE CLIP MAY BE INFLUENCED 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, FAILING TO RETRACT THE ACTUATOR KNOB UNTIL THE RELEASE PIN GROOVE IS FULLY EXPOSED, OR PREMATURELY RETRACTING THE DC HANDLE. IN THIS CASE, THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT 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 DC AND FROM THE LEAFLETS, INTO THE LEFT ATRIUM. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT RELEASE PIN WAS FULLY REMOVED AND THE ACTUATOR KNOB WAS ROTATED 8 TIMES; HOWEVER, THE ACTUATOR KNOB WAS NOT RETRACTED SO THE RELEASE PIN GROOVE WAS EXPOSED. THIS RESULTED IN THE CLIP NOT BEING FULLY DEPLOYED, SINCE THE COUPLER WAS NOT FULLY RETRACTED IN ORDER TO RELEASE THE L-LOCK TABS FROM THE CLIP. BASED ON THE INFORMATION REVIEWED, THE REPORTED INABILITY TO DEPLOY THE CLIP AND SUBSEQUENT DETACHMENT OF A THE CLIP APPEARS TO BE RELATED TO USER TECHNIQUE/PROCEDURAL CONDITIONS, AS THE FAILURE TO FULLY RETRACT THE ACTUATOR KNOB SO THE RELEASE PIN GROOVE IS EXPOSED RESULTED IN THE CLIP NOT BEING FULLY DEPLOYED FROM THE DEVICE. WHEN THE DC HANDLE WAS RETRACTED INTO THE LA, AS REPORTED, THIS RESULTED IN THE CLIP BEING RETRACTED, DETACHING THE CLIP FROM THE LEAFLETS AND FROM THE DC HANDLE (CLIP REMAINED ON GRIPPER LINE). THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). IT WAS REPORTED THAT UPON DEPLOYING THE CLIP, THE ACTUATOR KNOB WAS NOT RETRACTED ENOUGH SO THE RELEASE PIN GROOVE WAS FULLY EXPOSED. IT SHOULD BE NOTED THAT IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), STATES: RELEASE THE DC FASTENER THEN RETRACT THE ACTUATOR KNOB AFTER IT IS FULLY UNTHREADED. CONFIRM THAT THE RELEASE PIN GROOVE IS FULLY EXPOSED. IN THIS CASE, FAILURE TO CONFIRM THAT THE RELEASE PIN GROOVE WAS FULLY EXPOSED PRIOR TO RETRACTING THE DC HANDLE RESULTED IN THE REPORTED INABILITY TO THE DEPLOY THE CLIP AND DETACHMENT OF DEVICE COMPONENT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS MITRACLIP REPORT IS BEING FILED AS THE CLIP (40609U407) WAS DIFFICULT TO DEPLOY AND REQUIRED INTERVENTION FOR REMOVAL. 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
    661257 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40609U4

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention STEERABLE GUIDING CATHETER1 MITRACLIP