BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3851994 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03612
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MITRACLIP REMAINS IMPLANTED ON THE ANTERIOR MITRAL VALVE LEAFLET. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED BY THE REPORTER TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) LEADING TO INCOMPLETE COAPTATION ARE, BUT NOT LIMITED TO, MANUFACTURING ANOMALIES, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE AND PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO GRASP THE LEAFLETS). 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 CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP AND ITS COMPONENTS WERE FUNCTIONING AS EXPECTED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR SLDA INCIDENTS REPORTED FOR THIS LOT. THERE WERE NO REPORTED ISSUES WHILE FUNCTIONALLY INSPECTING THE CLIP DELIVERY SYSTEM (CDS) DURING 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, THE 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. IN THIS CASE, THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT THE PATIENT HAD A MITRAL VALVE AREA THAT WAS SMALLER THAN THE RECOMMENDED 4CM2, AND THAT THE POSTERIOR LEAFLET WAS RESTRICTED. ADDITIONALLY, VISUALIZATION WAS REPORTED TO NOT BE AS IDEAL DUE TO THE SHORT AND RESTRICTED POSTERIOR LEAFLET. DUE TO THE SMALLER VALVE AREA, A SINGLE ORIFICE WAS USED INSTEAD OF A DOUBLE ORIFICE TO EVALUATE CLIP GRASPING. THE CLIP WAS GRASPED TO THE LEAFLET AND IT WAS FELT THAT THE CLIP HAD A GOOD ENOUGH GRASP WITH ENOUGH LEAFLET INSERTION; HOWEVER, AS REPORTED BY THE PHYSICIAN, DUE TO THE SUBOPTIMAL VISUALIZATION, THE INSERTION MAY NOT HAVE BEEN FULLY APPRECIATED. THE CLIP WAS DEPLOYED AND AFTER 5 MINUTES, THE CLIP DETACHED FROM THE POSTERIOR LEAFLET. THERE WAS NO CHORDAE INVOLVEMENT OR LEAFLET DAMAGE NOTED, AND DURING DEPLOYMENT, THE CLIP PERFORMED AS INTENDED. THE CLIP WAS EXAMINED AND WAS FOUND TO HAVE AT LEAST 5MM OF THE ANTERIOR LEAFLET INSERTED AND WAS SECURE. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS (RESTRICTED POSTERIOR LEAFLET AND SUBOPTIMAL VISUALIZATION), AND NOT A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: LIFT, SUPPORT PLATE, STABILIZER, STEERABLE GUIDE CATHETER,. THE CLIP REMAINS IMPLANTED ON THE ANTERIOR MITRAL VALVE LEAFLET. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED SECURELY ATTACHED TO THE ANTERIOR LEAFLET. ALTHOUGH THERE WAS NO ADVERSE PATIENT EFFECT, A CLIP DETACHMENT FROM ONE LEAFLET HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED ON A PATIENT THAT HAD DEGENERATIVE MITRAL REGURGITATION (MR) AND THE MITRAL VALVE AREA WAS SMALLER (2CM2) THAN THE RECOMMENDED 4CM. THE PATIENT WAS CLASSIFIED AS A PROHIBITED RISK FOR MITRAL VALVE SURGERY. DURING THE MITRACLIP PROCEDURE, AFTER THE FIRST PLACEMENT ON THE A2P2 SEGMENT, THE MEAN PRESSURE GRADIENT JUMPED TO 17MMHG. THEREFORE CLIP WAS RELEASED AND INSTEAD OF A DOUBLE ORIFICE, DUE TO THE SMALLER VALVE AREA, A SINGLE ORIFICE WAS USED. THE CLIP WAS GRASPED TO THE LEAFLET AND IT WAS FELT THAT THE CLIP HAD A GOOD GRASP WITH ENOUGH LEAFLET INSERTED INTO THE CLIP ARMS. ALL IMAGING WAS USED. THE CLIP WAS DEPLOYED; HOWEVER, AFTER APPROXIMATELY 60 SECONDS, THE CLIP DETACHED FROM THE POSTERIOR LEAFLET. THERE WAS NO CHORDAL INVOLVEMENT OR LEAFLET DAMAGE NOTED. DURING DEPLOYMENT, THE DEVICE PERFORMED AS INTENDED. THE ANTERIOR CLIP WAS EXAMINED AND IT WAS DETERMINED THAT THE CLIP HAD AT LEAST 5MM OF THE LEAFLET INSERTED AND WAS SECURE. THE MITRACLIP PROCEDURE WAS ABORTED. THE MR GRADE REMAINED AT THE PREPROCEDURE GRADE OF 3. POST PROCEDURE THE PATIENT WAS EXTUBATED AND WAS FINE. NO ADDITIONAL MEDICATION WAS ADMINISTERED AND NO FURTHER TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POSTERIOR LEAFLET WAS RESTRICTED. REGARDING VISUALIZATION DURING THE PROCEDURE, IN HINDSIGHT, DUE TO THE SHORT, RESTRICTED POSTERIOR LEAFLET, THE LEAFLET INSERTION INTO THE CLIP ARMS WAS PERHAPS NOT FULLY APPRECIATED. DURING THE PROCEDURE, THE IMPRESSION WAS THAT REASONABLE INSERTION WAS MADE. THE CLIP WAS STILL ATTACHED TO THE VALVE AFTER THE INITIAL MECHANICAL DETACHMENT OF THE CLIP DELIVERY SYSTEM (CDS). THE LEAFLET DETACHMENT FROM THE POSTERIOR LEAFLET OCCURRED APPROXIMATELY 5 MINUTES AFTER CLIP DEPLOYMENT AND WAS NOTED DURING THE FINAL MR ASSESSMENT PRIOR TO CATHETER REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328640 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10308615

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR