BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3941391 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04590
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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 MITRACLIP REMAINS IMPLANTED ON THE ANTERIOR MITRAL LEAFLET. THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED BY THE REPORTER TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) LEADING TO INCOMPLETE COAPTATION OF THE LEAFLETS ARE, BUT 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. 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 RECORDS CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP AND ITS INNER COMPONENTS ACTUATED AS EXPECTED. THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. THERE WERE NO REPORTED DEVICE ISSUES WHILE FUNCTIONALLY INSPECTING THE CLIP DELIVERY SYSTEM 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, SLDA 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. THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT IT TOOK 9 ATTEMPTS TO GRASP THE LEAFLETS; HOWEVER, THERE WAS NO DIFFICULTY WITH PATHOLOGY OR VISUALIZATION. IN THIS CASE, IT IS POSSIBLE THAT THE POSTERIOR LEAFLET WAS NOT SUFFICIENTLY GRASPED AND RESULTED IN THE SLDA; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED AND WITHOUT THE DEVICE TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED SLDA/INCOMPLETE COAPTATION CANNOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED AGE (DATE OF BIRTH 1938). THE MITRACLIP REMAINS IMPLANTED ON THE ANTERIOR MITRAL LEAFLET. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS REPORT IS FILED AS AFTER THE CLIP WAS IMPLANTED, IT DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. A CLIP DETACHING FROM A LEAFLET HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, IT TOOK NINE ATTEMPTS TO GRASP THE MITRAL VALVE LEAFLETS WITH THE CLIP; THERE WAS NO DIFFICULTY WITH PATHOLOGY OR VISUALIZATION. ONCE THE LEAFLETS WERE GRASPED, THE CLIP WAS CLOSED AS PER THE INSTRUCTIONS FOR USE TO THE DESIRED ANGLE OF 20 DEGREES. AFTER RETRACTING THE LOCK LINE, IT WAS OBSERVED THAT THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THERE WAS NO OBSERVED LEAFLET DAMAGE. IT WAS NOT POSSIBLE TO PLACE ANOTHER CLIP. NO FURTHER INTERVENTION WAS PLANNED DUE TO THE POSTERIOR LEAFLET DETACHMENT. POST PROCEDURE, THE PATIENT WAS STABLE. ALTHOUGH THE CLIP DETACHED FROM THE ANTERIOR LEAFLET, THE FUNCTIONAL MITRAL REGURGITATION GRADE WAS REDUCED FROM 4 TO 2-3. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418295 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10317545

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER