BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3854278 · Received June 6, 2014

    Report

    Report Number
    2024168-2014-03641
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER, 2 IMPLANTED MITRACLIPS. THE MITRACLIP CLIP DELIVERY SYSTEM IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND THE ANALYSIS OF THE RETURNED PRODUCT WERE REVIEWED. THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND POST PROCEDURE HANDLING. THE REPORTED ACTUATOR KNOB DETACHMENT WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE MATING SURFACES BETWEEN THE TWO PIECES (ACTUATOR KNOB AND RELEASE CRIMPER) WERE EXAMINED NEXT TO DETERMINE THE CAUSE OF THE DETACHMENT. ADHESIVE (LOCTITE) WAS VERIFIED TO BE PRESENT INSIDE THE ACTUATOR KNOB AND ON THE RELEASE CRIMPER. THE ADHESIVE WAS TACTICALLY EXAMINED AND IDENTIFIED TO BE HARD, AND THUS FULLY CURED. SCRATCHES WERE NOTED ON THE RELEASE CRIMPER SHAFT WHICH WAS LIKELY DUE TO THE USE OF THE SURGICAL CLAMP ON THE RELEASE CRIMPER TO DEPLOY THE CLIP. THE ACTUATOR KNOB SURFACE WAS INSPECTED NEXT AND INDENTATION WAS NOTED ON THE KNOB FROM WHAT APPEARED TO BE DUE TO AN IMPACT. THIS WAS LIKELY DUE TO THE KNOB DETACHING AND FALLING OFF DURING THE PROCEDURE. THEREFORE, THE INDENTATION AND SCRATCHING IS ATTRIBUTED TO OPERATIONAL CONTEXT. THE ACTUATOR KNOB INNER DIAMETERS (IDS) WERE MEASURED, AND WITHIN SPECIFICATION. THE RELEASE CRIMPER SHAFT OUTER DIAMETER (OD), HEX LENGTH AND SHAFT LENGTH WERE MEASURED, AND WITHIN SPECIFICATION. POTENTIAL CAUSES FOR ACTUATOR KNOB DETACHMENT CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING ANOMALIES (LOCTITE AND / OR ACCELERATOR NOT APPLIED OR FULLY CURED, RESULTING IN DETACHMENT), PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY / PATHOLOGY), USER TECHNIQUE OR PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING PROCEDURE). 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 (DHR) CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS INCLUDING VERIFICATION THAT THE KNOB IS ATTACHED TO THE RELEASE CRIMPER. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND A REVIEW OF COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS OF ACTUATOR KNOB DETACHMENT REPORTED FOR THIS LOT. THE USER ALSO REPORTED NO ISSUE WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREP, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. ADDITIONALLY, THE ACTUATOR KNOB WAS FURTHER ANALYZED VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND THE ANALYSIS CONFIRMED THE PRESENCE OF LOCTITE AND ACCELERATOR INSIDE THE ACTUATOR KNOB. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, ACTUATOR KNOB DETACHMENT MAY BE INFLUENCED BY PATIENT ANATOMICAL MORPHOLOGY, RESULTING IN INCREASED TENSION ON THE DEVICE, EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER, OR THE HANDLING OF THE DEVICE BY THE USER. IT WAS CONFIRMED BY THE THERAPY SPECIALIST THAT THE DC HANDLE WAS NOT TRANSLATED, BUT WERE NO TURNS ON THE DC HANDLE AND THE ARM POSITIONER WAS IN NEUTRAL BEFORE CLIP DEPLOYMENT; HOWEVER, IN THIS CASE IT IS POSSIBLE THAT THERE WERE SOME PROCEDURAL INTERACTIONS WHICH CAUSED MORE TENSION ON THE DEVICE (E.G DUE TO THE ANATOMY, STORED TORQUE ETC.) AND/OR THE MOVEMENT OF THE LEAFLETS TO THE ATTACHED CLIP, THAT MAY HAVE LED THE ACTUATOR KNOB TO DETACH WHEN THE ACTUATOR KNOB ASSEMBLY WAS NO LONGER COUPLED DURING CLIP DEPLOYMENT STEPS. HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE ACTUATOR KNOB DETACHMENT CANNOT 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 REPORTED FOR THE SEPARATION OF THE ACTUATOR KNOB WHICH OCCURRED DURING USE WITH THE CLIP DELIVERY SYSTEM (CDS 10325055/07), AND REQUIRED MEDICAL INTERVENTION TO DEPLOY THE CLIP. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS WERE IMPLANTED WITHOUT ISSUE. THE THIRD CDS (10325055/07) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT ANY ISSUES NOTED. AFTER SUCCESSFUL GRASPING, THE CLIP WAS DEPLOYED PER THE IFU. THE ARM POSITIONER WAS IN NEUTRAL AND THE RELEASE PIN WAS PULLED, BUT AS SOON AS THE PIN WAS PULLED, THE ACTUATOR KNOB SEPARATED. THE ACTUATOR HAD NOT BEEN TURNED AT ALL BEFORE THE SEPARATION OCCURRED. THERE WERE NO TURNS ON THE DELIVERY CATHETER (DC) HANDLE PRIOR TO REMOVING THE RELEASE PIN AND THE SLEEVE WAS NOT CURVED MORE THAN 90 DEGREES AT ANY POINT. ADDITIONALLY, IT WAS CONFIRMED THAT THE DC HANDLE WAS NOT TRANSLATED TO RELEASE THE STORED TORQUE. THE PHYSICIAN WAS ABLE TO TURN THE ACTUATOR ROD USING A SURGICAL CLAMP AND THE CLIP WAS SUCCESSFULLY DEPLOYED. THE MR WAS REDUCED TO 1 WITH THE IMPLANTATION OF THREE CLIPS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332837 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10325055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention