BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3970875 · Received July 31, 2014

    Report

    Report Number
    2024168-2014-04889
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 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). 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 SINGLE LEAFLET DEVICE ATTACHMENT (SLDA-THE DEPLOYED CLIP IS ONLY ATTACHED TO ONE LEAFLET, INSTEAD OF TWO)LEADING TO INCOMPLETE COAPTATION CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE/PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO GRASP THE LEAFLETS) OR MANUFACTURING ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP AND ITS COMPONENTS WERE FUNCTIONING AS EXPECTED. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE ELECTRONIC COMPLAINT HISTORY FOUND NO SIMILAR INCIDENTS OF SINGLE LEAFLET DEVICE ATTACHMENT REPORTED FROM THIS LOT. THE USER ALSO REPORTED NO ISSUES WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. WITH RESPECT TO THE PATIENT CONDITIONS, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE DIFFICULTY IN GRASPING BOTH LEAFLETS MAY BE INFLUENCED BY THE DIFFICULTIES WITH VISUALIZATION OR MORPHOLOGY OF THE MITRAL VALVE, INCLUDING TETHERING OF THE LEAFLETS, CHORDAE INTERACTION, OR LEAFLETS THAT ARE THINNER/THICKER, RESTRICTED AND PROLAPSED. IT WAS NOTED THAT THERE WAS A MINOR PROLAPSE ON THE A2 SEGMENT AND THAT LEAFLET ASSESSMENT WAS CHALLENGING DUE TO A SMALL, TETHERED, AND HIGHLY CALCIFIED POSTERIOR LEAFLET. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS/ MORPHOLOGY OF THE MITRAL VALVE AS THE MINOR PROLAPSE IN THE A2 SEGMENT AND CHALLENGING POSTERIOR LEAFLET ANATOMY LIKELY CONTRIBUTED TO THE SLDA. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MITRACLIP REMAINS IN THE PATIENT ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS SECOND MITRACLIP IS BEING FILED FOR SINGLE LEAFLET DEVICE ATTACHMENT, WHICH HAS POTENTIAL OF SERIOUS INJURY. IT WAS REPORTED THAT A FIRST MITRACLIP WAS IMPLANTED WITHOUT INCIDENT IN THE PATIENT WITH DEGENERATIVE MITRAL REGURGITATION (MR) WITH A MINOR PROLAPSE ON A2. THE SECOND MITRACLIP WAS POSITIONED ON THE LEAFLETS AFTER THREE GRASPS. LEAFLET ASSESSMENT WAS CHALLENGING DUE TO THE SMALL, TETHERED, AND HIGHLY CALCIFIED POSTERIOR LEAFLET. THERE WERE NO DIFFICULTIES WITH CLIP VISUALIZATION AND NO OTHER DIFFICULTIES WITH CLIP IMPLANTATION. LEAFLET ASSESSMENT WAS CONFIRMED AND IT WAS DECIDED TO DEPLOY THE SECOND MITRACLIP. MR WAS REDUCED FROM 4 DOWN TO 2. AFTER THE STEERABLE GUIDE CATHETER (SGC) WAS REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THE SECOND MITRACLIP HAD A SINGLE LEAFLET DEVICE ATTACHMENT AND HAD DETACHED FROM THE ANTERIOR LEAFLET. THE CLIP REMAINED ATTACHED TO THE POSTERIOR LEAFLET. MR WAS 3 AT THE END OF THE PROCEDURE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447123 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40513U2

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR STEERABLE GUIDE CATHETER, IMPLANTED MITRACLIP (X1)