BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3884973 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03962
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR SLEEVE STEERING ISSUES/DIFFICULTY POSITIONING THE CDS CAN INCLUDE, BUT ARE 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). REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE STEERABLE SLEEVE PROPERLY CURVED AND FUNCTIONED AS EXPECTED. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, SLEEVE STEERING ISSUES 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 DURING THE PROCEDURE OR EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER. BASED ON THE INFORMATION REVIEWED AND WITHOUT THE DEVICE TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED SLEEVE STEERING ISSUE COULD NOT BE DETERMINED; HOWEVER, THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO NON-CONFORMANCES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A SIMILAR ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE MITRACLIP WILL NOT BE RETURNED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THE STEERING ISSUE THAT OCCURRED WITH THE MITRACLIP CLIP DELIVERY SYSTEM (CDS 10324095/28). IT IS UNKNOWN IF THE STEERING ISSUE OCCURRED IN THE LEFT ATRIUM (LA) OR THE LEFT VENTRICLE (LV). STEERING ISSUE IN THE LV HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO INJURY, THEREFORE, THIS IS CONSERVATIVELY FILED. IT WAS REPORTED THAT THIS WAS AN UNPROCTORED MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 2-3. DURING USE WITH THE CLIP DELIVERY SYSTEM (CDS 10324095/28), THE CDS DID NOT MOVE IN THE RIGHT DIRECTION WHEN THE M-KNOB APPLIED. IT IS UNKNOWN IF THIS OCCURRED IN THE LA OR THE LV. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE PREPARATION OR TROUBLESHOOTING STEPS PERFORMED WITH THE CDS. A NEW CDS WAS USED. THE PROCEDURE WAS COMPLETED WITH 3 CLIPS IMPLANTED AND THE MR WAS REDUCED TO 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT EXITED THE CATH LAB IN CLINICALLY STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362042 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10324095

    Patients

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