BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3912876 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04348
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 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). EVENT DESCRIPTION CONTINUED: THE CLIP WAS SUCCESSFULLY IMPLANTED. AN ADDITIONAL 3 CDS DEVICES WERE USED AND THE CLIPS WERE SUCCESSFULLY IMPLANTED. THE MIXED MITRAL REGURGITATION WAS REDUCED FROM 4 TO 1-2 WITH THE IMPLANTATION OF 5 CLIPS. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE CLIP DELIVERY SYSTEM WAS REPORTED AS BEING DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE STEERABLE GUIDE CATHETER (SGC 10300725/18) REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR THE REPORTED DIFFICULTY IN REMOVING THE CDS FROM THE SGC CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING ANOMALIES (SLEEVE KEY ORIENTATION), PATIENT CONDITIONS SUCH AS ANATOMICAL MORPHOLOGY / PATHOLOGY, USER TECHNIQUE OR PROCEDURAL CONDITIONS (FORCE APPLIED TO THE SGC HEMOSTASIS LUER / HEMOSTASIS VALVE DURING INSERTION ATTEMPTS). WITH RESPECT TO THE PATIENT ANATOMY, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, DIFFICULTY IN REMOVING THE CDS FROM THE SGC MAY BE INFLUENCED BY HANDLING OF THE DEVICE DURING INSERTION / REMOVAL OF THE CDS OR TORQUEING OF THE SLEEVE DURING REMOVAL. THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT FOLLOWING DEPLOYMENT OF THE CLIP, THE CDS WAS BEING REMOVED, AND RESISTANCE WAS MET WHILE REMOVING THE LAST 8CM OF THE DEVICE. AFTER MANIPULATION OF THE DEVICE, THE CDS WAS ABLE TO BE REMOVED. EVALUATION OF THE RETURNED SGC DEVICE IDENTIFIED THAT THE SGC HEMOSTASIS VALVE BOND WAS LOOSE AND BROKEN. BASED ON THE INFORMATION PROVIDED, THE REPORTED DIFFICULTY IN REMOVAL OF THE CDS FROM THE SGC WAS RELATED TO THE MISORIENTATION OF THE KEYWAY AS A RESULT OF A LOOSE HEMOSTASIS VALVE BOND. THERE IS NO EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS (CDS) DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE PACKAGING WAS INTACT. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND A REVIEW OF THE ELECTRONIC COMPLAINT HISTORY FOUND NO SIMILAR INCIDENTS FROM THE REPORTED LOT. THE USER ALSO REPORTED NO ISSUES WHILE INSERTING THE DEVICE, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING AS INTENDED AND THAT THE KEYWAYS WERE ALIGNED DURING INSERTION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO PROBLEMS DURING INSERTION OF THE DEVICE; THERE WAS NO TWISTING OR MOTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS DURING THE REMOVAL OF THE CLIP DELIVERY SYSTEM (CDS 10340935/13) RESISTANCE WAS MET. ALTHOUGH THERE WAS NO ADVERSE PATIENT INJURY, RESISTANCE DURING REMOVAL HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, THE CLIP DELIVERY SYSTEM (CDS 10340935/13) WAS INSERTED AND ADVANCED THROUGH THE SGC (10300725/18) WITH NO DIFFICULTIES. AS PER THE INSTRUCTIONS FOR USE (IFU), THE SGC TIP HAD BEEN STRAIGHTENED PRIOR TO THE INSERTION OF THE CDS AND THE CDS SLEEVE HAD NOT BEEN CURVED MORE THAN 90 DEGREES AT ANY TIME. THE PATIENT ANATOMY WAS NOT CHALLENGING. THERE WAS AN ANTERIOR FLAIL AND A RESTRICTIVE POSTERIOR LEAFLET. THE CLIP WAS DEPLOYED WITHOUT ANY REPORTED DIFFICULTIES. UPON RETRACTING THE CDS THROUGH THE SGC, RESISTANCE WAS MET DURING THE REMOVAL OF THE LAST 8CM. THE CDS COULD NOT BE RETRACTED ANY FURTHER. AFTER A FEW MINUTES OF TURNING AND SLIDING THE DEVICE IN AND OUT, THE CDS WAS ABLE TO BE FULLY RETRACTED FROM THE SGC. THERE WAS NO DAMAGE NOTED TO THE CDS. THE SECOND CDS WAS INSERTED AND THE BLUE ALIGNMENT LINES OF THE CDS AND SGC WERE CONFIRMED TO BE IN ALIGNMENT. AFTER THE CDS WAS ADVANCED TO APPROXIMATELY 1CM BEHIND THE KEY, RESISTANCE WAS MET AND THE CDS COULD NOT BE ADVANCED ANY FURTHER. AFTER SEVERAL ATTEMPTS, THE CDS WAS REMOVED. THE SGC WAS REMOVED FROM THE ANATOMY; THERE WAS NO DAMAGE NOTED. USING ANOTHER SGC, THE SECOND CDS WAS ABLE TO BE REINSERTED AND ADVANCED TO THE LEFT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391278 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10340935

    Patients

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