BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4173622 · Received October 15, 2014

    Report

    Report Number
    2024168-2014-06709
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 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). CONCOMITANT PRODUCT: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER (SGC 10338515/(B)(4)). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE SGC (10338515/(B)(4)) AND CDS (40418U1/(B)(4)) REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS, COMPLAINT HISTORY AND THE ANALYSIS OF THE RETURNED DEVICE WERE REVIEWED. THE CLIP INTRODUCER (CI) TIP MATERIAL WAS OBSERVED TO BE TORN AND A PIECE OF TORN MATERIAL WAS DETACHED; THE DETACHED PIECE WAS LOCATED ON THE FRICTIONAL ELEMENTS (FES) BETWEEN ONE OF THE CLIP ARMS AND GRIPPERS. ONE GRIPPER WAS NOTED TO BE SLIGHTLY BENT; CONFIRMING THE REPORTED DAMAGE. A SLEEVE STEERING ISSUE WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. DURING REMOVAL OF THE CLIP DELIVERY SYSTEM (CDS), THE LONGITUDINAL ALIGNMENT MARKERS WERE OBSERVED TO OFFSET BY 90 DEGREES. FURTHER INSPECTION OF THE SLEEVE KEY NOTED THAT IT WAS ABLE TO ROTATE AROUND THE STEERABLE SLEEVE SHAFT AND CONFIRMED TO BE LOOSE. THE ACTUATOR MANDREL WAS IDENTIFIED TO BE BENT. THE REPORTED DIFFICULTY RETRACTING THE CLIP INTO THE GUIDE TIP WAS CONFIRMED. ALTHOUGH A SLEEVE STEERING ISSUE WAS IDENTIFIED, THE OBSERVATION WAS ATTRIBUTED TO DEVICE TESTING AND UNRELATED TO THE REPORTED EXPERIENCE. THE DISCREPANCY BETWEEN WHAT WAS REPORTED (SLEEVE DEFLECTED POSTERIORLY AND MEDIAL) AND WHAT WAS OBSERVED (SLEEVE JUMPED IN THE POSTERIOR DIRECTION) WAS LIKELY DUE TO A COMBINATION OF VARYING AMOUNTS OF TENSION FELT BY THE DEVICE DURING THE PROCEDURE VERSUS THE RETURNED PRODUCT ANALYSIS AND INTERNAL DAMAGE TO THE ACTUATOR ASSEMBLY. MORE TENSION ON THE DEVICE (E.G. DUE TO THE ANATOMY, CURVES ON THE DEVICE, ETC.) AND/OR INTERNAL DAMAGE (SUCH AS BENDS) MAY MAKE IT MORE DIFFICULT TO POSITION THE DEVICE. POTENTIAL CAUSES FOR SLEEVE STEERING ISSUES, RESULTING IN THE DIFFICULTY POSITIONING THE CDS CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, USER TECHNIQUE/PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING THE PROCEDURE) OR MANUFACTURING ANOMALIES (LOOSE OR MISALIGNED SLEEVE KEY). WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, SLEEVE STEERING ISSUES MAY BE INFLUENCED BY PATIENT ANATOMICAL MORPHOLOGY AND PATIENT DISEASE STATE (SUCH AS TORTUOSITY OF THE VESSEL, RESULTING IN INCREASED TENSION ON THE DEVICE), UNINTENDED CURVES ON THE DEVICE DURING THE PROCEDURE OR EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER. BASED ON THE INFORMATION REVIEWED, IT IS POSSIBLE THAT THERE WERE UNIDENTIFIED PROCEDURAL INTERACTIONS (E.G. UNINTENDED CURVES ON THE DEVICE AND/OR PATIENT ANATOMY) WHICH RESULTED IN INCREASED TENSION ON THE DEVICE, SUCH THAT THE ACTUATOR MANDREL BECAME BENT AND THEREFORE CONTRIBUTED THE SLEEVE STEERING ISSUE/DIFFICULTY POSITIONING THE DEVICE; HOWEVER, THIS CANNOT BE CONFIRMED. ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO THE REPORTED SLEEVE STEERING ISSUE DURING ISSUE. DIFFICULTY RETRACTING THE CLIP INTO THE GUIDE TIP CAN BE INFLUENCED BY, BUT ARE NOT LIMITED TO, PROCEDURAL CONDITIONS (CURVES ON THE GUIDE DURING CDS REMOVAL), USER TECHNIQUE, SUCH AS CLIP NOT BEING FULLY CLOSED UPON REMOVAL, THE ORIENTATION OF THE CLIP WITH RESPECT TO THE GUIDE TIP, OR MANUFACTURING ANOMALIES. BASED ON THE INFORMATION REVIEWED, THE DIFFICULTY REMOVING THE CDS/CLIP CAUGHT ON GUIDE TIP, TEARS IN THE SOFT TIP, AND DAMAGE TO THE CI APPEAR TO BE RELATED TO USER TECHNIQUE/PROCEDURAL CONDITIONS AND NOT A PRODUCT QUALITY DEFICIENCY. THE NOTED LOOSE SLEEVE KEY, WHICH WAS IDENTIFIED DURING WATER BATH TESTING, DOES NOT APPEAR TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE HAVE BEEN NO OTHER INCIDENTS FOR REPORTED FOR DIFFICULTY REMOVING THE DEVICE/CLIP CAUGHT ON GUIDE TIP OR A BENT GRIPPER FROM THIS LOT.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THE RESISTANCE NOTED DURING REMOVAL OF THE CLIP DELIVERY SYSTEM (40414U2/(B)(4)). IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 3. THE FIRST CLIP DELIVERY SYSTEM (CDS 40414U2/(B)(4)) WAS INSERTED INTO THE STEERABLE GUIDING CATHETER (SGC 10338515/(B)(4)) AND ADVANCED TO THE MITRAL VALVE. AN ATTEMPT WAS MADE TO STEER THE CLIP WITH M-KNOB, BUT THE CLIP MOVED UPWARD. DIFFERENT GUIDE POSITIONS WERE ATTEMPTED, BUT WERE UNSUCCESSFUL. THE CDS WAS RETRACTED, BUT THE CLIP BECAME STUCK ON THE TIP OF THE SGC. WITH FORCEFUL PUSHING, THE CLIP WAS FREED, AND REMOVED FROM THE ANATOMY. THE GRIPPERS WERE NOTED TO BE BENT; THEREFORE, THIS CDS WAS REPLACED. A NEW CDS (40414U2/(B)(4)) WAS INSERTED INTO THE SAME SGC, BUT THE SAME MOVEMENT WAS OBSERVED WHILE TURNING THE M-KNOB. THE CDS WAS REMOVED, AND IT WAS FOUND THAT THE TIP OF THE SGC WAS TORN. A NEW SGC WAS USED TO CONTINUE THE PROCEDURE. THE CDS (40414U2/(B)(4)) WAS RE-ADVANCED AND THE CLIP WAS DEPLOYED. THE MR WAS REDUCED TO 1-2. THE NEXT CDS (40418U1/(B)(4)) WAS ADVANCED TO THE MITRAL VALVE, BUT THERE WAS NO SUFFICIENT MR REDUCTION WITH THE CLIP, SO THE CLIP WAS NOT DEPLOYED. DURING RETRACTION OF THE CDS, THE CLIP BECAME STUCK, BUT IT IS UNKNOWN WHAT THE CLIP WAS STUCK ON. DURING AN ATTEMPT TO FREE THE CLIP, IT JUMPED VERY LATERAL IN THE HEIGHT OF THE LEAFLETS, AND WAS FREED. THE CDS WAS REMOVED SUCCESSFULLY. THE PATIENT WAS IN A STABLE CONDITION POST-PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653830 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40414U2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CONCOMITANT MEDICAL DEVICES