BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4233341 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07274
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. ESTIMATED AGE (YEAR OF BIRTH 1923). CONCOMITANT MEDICAL PRODUCTS: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP. THE CLIP DELIVERY SYSTEM IS EXPECTED TO BE RETURNED. THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT SUMMARY: THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED FOR INSPECTION. DURING TESTING, THE CDS SHAFT WAS FOUND TO DEFLECT MEDIALLY, CONFIRMING THE REPORTED EVENT. A BEND IN AN INNER DEVICE COMPONENT, ACTUATOR MANDREL, WAS IDENTIFIED. BASED ON THE ANALYSIS FINDINGS, THE BENDING/CURVING OF THE CDS SHAFT APPEARS TO BE RELATED TO THE BENT ACTUATOR MANDREL. ALTHOUGH THE REPORTED DIFFICULT TO POSITION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT, THE BEND IN THE MANDREL AND THUS CDS SHAFT LIKELY RESULTED IN THE DIFFICULTY POSITIONING OF THE DEVICE. POTENTIAL CAUSES FOR DIFFICULTY POSITIONING THE CDS ARE, BUT NOT LIMITED TO, PATIENT CONDITIONS SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, USER TECHNIQUE/PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING THE PROCEDURE) OR MANUFACTURING ANOMALIES (LOOSE OR MISALIGNED SLEEVE KEY). AS PART OF THE MITRACLIP MANUFACTURING PROCESS, ALL DEVICES ARE SUBJECT TO VISUAL AND FUNCTIONAL INSPECTION TO VERIFY PRODUCT QUALITY. REVIEW OF THE LOT HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE STEERABLE SLEEVE PROPERLY CURVED AND FUNCTIONED AS EXPECTED. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO INCIDENTS REPORTED FOR THIS LOT. THERE WERE NO REPORTED DEVICE ISSUES WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, DIFFICULTY POSITIONING THE CDS MAY BE INFLUENCED BY PATIENT ANATOMICAL MORPHOLOGY, SUCH AS TORTUOSITY OF THE VESSEL, RESULTING IN INCREASED TENSION ON THE DEVICE OR EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER. BASED ON THE INFORMATION REVIEWED, IT IS POSSIBLE THAT THERE WERE PROCEDURAL INTERACTIONS (DUE TO THE PATIENT ANATOMY AND/OR UNINTENDED CURVES ON THE SYSTEM) WHICH RESULTED IN INCREASED TENSION ON THE DEVICE, SUCH THAT THE MANDREL BECAME BENT AND SUBSEQUENTLY, CAUSED THE CDS SHAFT TO BEND/DIFFICULTY POSITIONING THE DEVICE; HOWEVER, THIS CANNOT BE CONFIRMED. ALTHOUGH THE REPORTED DIFFICULTY POSITIONING THE DEVICE APPEARS TO BE RELATED TO THE BEND IN THE MANDREL, A CAUSE FOR HOW AND WHEN THE BEND OCCURRED CANNOT BE DEFINITIVELY IDENTIFIED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS THE CLIP DELIVERY SYSTEM (CDS 40711U1/14) WAS IN THE LEFT VENTRICLE AND THE CLIP MOVED IN AN UNEXPECTED DIRECTION. ALTHOUGH THERE WAS NO ADVERSE PATIENT EFFECT, UNEXPECTED MOVEMENT OF THE CLIP IN THE LEFT VENTRICLE HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, ONE CLIP WAS IMPLANTED ON THE MITRAL VALVE LEAFLETS. WHILE IN THE LEFT VENTRICLE WHEN ATTEMPTING TO PLACE A SECOND CLIP (40711U1/14), THE CLIP MOVED MEDIALLY AND LATERALLY AS IT WAS BEING LOCKED AND UNLOCKED. SEVERAL ATTEMPTS WERE MADE TO COMPENSATE THIS MOVEMENT. THE NAVIGATION OF THE DEVICE WAS STILL DIFFICULT AND AS THIS WAS THE SECOND CLIP, A SHORT OF DISTANCE TO THE FIRST CLIP WAS NEEDED. THEREFORE, THE DECISION WAS REMOVE THIS DEVICE. THE CDS WAS RETRACTED THROUGH THE STEERABLE GUIDE CATHETER WITHOUT ANY ISSUES AND ANOTHER CDS WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS. THE DEGENERATIVE MITRAL REGURGITATION GRADE WAS REDUCED FROM 4 TO 1-2 WITH THE IMPLANTATION OF TWO CLIPS. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713857 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40711U1

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR