BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3854261 · Received June 6, 2014

    Report

    Report Number
    2024168-2014-03639
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CLIP DELIVERY SYSTEM (CDS) WAS NOT RETURNED FOR EVALUATION, 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 FAILURE TO ADHERE OR BOND TO THE LEAFLETS AND THE CLIP BECOMING CAUGHT ON THE CHORDAE, RESULTING IN DIFFICULTY REMOVING THE DEVICE 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 VISUALIZE THE DEVICE IN RELATION TO THE MITRAL VALVE) 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 RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP AND STEERABLE SLEEVE FUNCTIONED AS EXPECTED. 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 OTHER INCIDENTS REPORTED FOR DIFFICULTY REMOVING THE DEVICE/CLIP CAUGHT ON CHORDAE OR FAILURE TO ADHERE OR BOND TO THE LEAFLETS FROM THIS LOT. THE USER ALSO REPORTED NO ISSUES WHILE FUNCTIONALLY INSPECTED 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, CLIP CAUGHT IN CHORDAE/DIFFICULT TO REMOVE MAY BE INFLUENCED BY MORPHOLOGY OF THE MITRAL VALVE, DIFFICULTIES VISUALIZING THE CLIP DURING PLACEMENT, EXCESSIVE FORCE OR RANGE OF ROTATION OF TRANSLATION WHILE MANIPULATING THE DEVICE. FURTHERMORE, DIFFICULTY GRASPING 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 THERE WERE NO DIFFICULTIES WITH VISUALIZATION, NO RESISTANCE DURING INSERTION OR ADVANCEMENT OF THE CDS THROUGH THE STEERABLE GUIDE CATHETER (SGC), NO ABNORMAL MOVEMENT OF THE DEVICE OR ANY EXTREME CURVES ON THE SGC. AFTER POSITIONING THE CLIP, THE LEAFLETS WERE GRASPED AFTER SEVERAL TIMES, BUT THE REMAINING MITRAL REGURGITATION (MR) WAS NOT ABLE TO BE REDUCED, SO THE CLIP WAS INVERTED IN THE LEFT VENTRICLE. THEN, AN ATTEMPT WAS MADE TO RETRACT THE CDS INTO THE LEFT ATRIUM, BUT TENSION AT THE CDS SLEEVE WAS OBSERVED. AS THE CLIP WAS CONTINUED TO BE RETRACTED, IT JUMPED BACK INTO LEFT ATRIUM. PER THE PHYSICIAN, IT WAS THOUGHT THAT THE CLIP WAS CAUGHT ON THE CHORDAE AND WAS THE CAUSE OF THE TENSION AND CHORDAE RUPTURE. DUE TO THE RUPTURED CHORDAE, AN UNSUCCESSFUL ATTEMPT TO GRASP THE LEAFLETS WAS PERFORMED. IN THIS CASE, IT IS LIKELY THAT THE CLIP INTERACTED WITH THE CHORDS UPON REMOVING THE DEVICE AFTER INVERTING THE CLIP, SUCH THAT IT BECAME ENTANGLED WITH THE CHORDS AND THEREFORE CONTRIBUTED TO THE DIFFICULT TO REMOVE AND SUBSEQUENT CHORDAE RUPTURE. AS A RESULT OF THE CHORDAE RUPTURE, THE LEAFLETS COULD NOT BE GRASPED AND THE PROCEDURE WAS ABORTED. BASED ON THE INFORMATION REVIEWED, THE REPORTED CLIP CAUGHT ON CHORDAE/DIFFICULT TO REMOVE, FAILURE TO ADHERE OR BOND TO THE LEAFLETS AND CHORDAE RUPTURE APPEAR TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS. THERE IS NO EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE. THE PATIENT EFFECTS OF MR AND MITRAL VALVE INJURY (CHORDAE RUPTURE/TISSUE DAMAGE), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. IN THIS CASE, THE MOST PROBABLE CAUSE FOR THE RECURRENT MR WAS DUE TO THE MITRAL VALVE INJURY (CHORDAE RUPTURE/TISSUE DAMAGE).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: LIFT, SUPPORT PLATE, STABILIZER, STEERABLE GUIDE CATHETER, IMPLANTED MITRACLIP (X2). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. 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 BECAME CAUGHT IN THE CHORDAE CAUSING THE CHORDAE TO RUPTURE. THE RUPTURED CHORDAE IS CONSIDERED PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, TWO CLIPS WERE IMPLANTED ON THE MITRAL VALVE LEAFLETS. THE MIXED MITRAL REGURGITATION (MR) GRADE WAS REDUCED FROM 3-4 TO 2. A THIRD CLIP (10320695/(B)(4))WAS USED. THERE WAS NO DIFFICULTY INSERTING OR ADVANCING THE THIRD DEVICE; NO ABNORMAL MOVEMENT WAS OBSERVED. THE CLIP WAS ADVANCED DOWN INTO THE LEFT VENTRICLE WITHOUT PROBLEMS. THE ECHOCARDIOGRAM AND FLUOROSCOPY IMAGING SHOWED THAT THE CLIP LOOKED FINE. THE CLIP WAS GRASPED TO THE LEAFLETS SEVERAL TIMES, BUT THE REMAINING MR WAS NOT ABLE TO BE REDUCED. UPON RETRACTING THE CLIP BACK INTO THE LEFT ATRIUM, TENSION AT THE CLIP DELIVERY SYSTEM (CDS) SLEEVE WAS OBSERVED AND THE CLIP JUMPED INTO LEFT ATRIUM. THE MR GRADE INCREASED BACK TO 3-4 AND A RUPTURED CHORDAE WAS NOTED. PER THE PHYSICIAN, IT WAS THOUGHT THAT THE CLIP WAS CAUGHT ON THE CHORDAE AND WAS THE CAUSE OF THE TENSION AND CHORDAE RUPTURE. DUE TO THE RUPTURED CHORDAE, ANOTHER UNSUCCESSFUL ATTEMPT TO GRASP THE LEAFLETS WAS PERFORMED. THE DEVICE WAS REMOVED AND THE MITRACLIP PROCEDURE WAS ABORTED. THE PATIENT WAS EXTUBATED AND WAS FINE. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL MEDICATION DUE TO THE UNCHANGED MR GRADE AND THE PHYSICIAN DOES NOT PLAN ON ANY FURTHER INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332964 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10320695

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other