BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4093241 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05954
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM, STEERABLE GUIDING CATHETER, IMPLANTED MITRACLIP (X1). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 PRODUCT WERE REVIEWED. THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED. SINCE THE DEVICE WAS USED DURING THE PROCEDURE, THE REPORTED CLIP BEING INVERTED OUT OF THE PACKAGING (OUT-OF-BOX FAILURE) COULD NOT BE CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE REPORTED BENDING/CURVING OF THE DELIVERY CATHETER (DC) SHAFT WAS CONFIRMED. POTENTIAL CAUSES FOR THE CLIP BEING INVERTED PRIOR TO USE CAN INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE (SUCH AS HANDLING DURING REMOVAL FROM THE PACKAGING AND/OR DEVICE PREPARATION) OR MANUFACTURING ANOMALIES. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE CLIP BEING INVERTED (OUT-OF-BOX FAILURE) CANNOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THE CLIP ITSELF. IN REGARDS TO THE REPORTED BEND IN THE DC SHAFT AND DIFFICULTY POSITIONING THE DEVICE, THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A SIGNIFICANT BEND IN THE MANDREL, WHICH LIKELY CAUSED THE BENDING/CURVING OF THE DC SHAFT AND THUS DIFFICULTY POSITIONING THE CLIP IN THE CORRECT POSITION OF THE JET AREA. THIS TYPE OF DAMAGE MAY BE INFLUENCED BY FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT CONDITIONS SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY (SUCH AS VESSEL TORTUOSITY RESULTING IN INCREASED TENSION ON THE DEVICE), USER TECHNIQUE/PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING THE PROCEDURE RESULTING IN DAMAGE TO THE INTERNAL COMPONENTS) OR MANUFACTURING ANOMALIES. BASED ON THE INFORMATION REVIEWED, IT IS POSSIBLE THAT THERE WERE UNIDENTIFIED PROCEDURAL INTERACTIONS (E.G. DUE TO THE PATIENT ANATOMY OR UNINTENDED CURVES ON THE SYSTEM) WHICH RESULTED IN INCREASED TENSION ON THE DEVICE, SUCH THAT THE MANDREL BECAME BENT AND SUBSEQUENTLY CAUSED THE DC SHAFT BENDING/DIFFICULTY POSITIONING THE CDS; HOWEVER, THIS CANNOT BE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT THAT THE IRREGULAR CLIP MOVEMENT (CDS 10339845/(B)(4)) WHICH OCCURRED IN THE LEFT VENTRICLE AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THERE WAS NO CHALLENGING ANATOMY OBSERVED. ONE CLIP WAS IMPLANTED SUCCESSFULLY AND THE MR WAS REDUCED TO 3-4. THE SECOND CLIP DELIVERY SYSTEM (CDS 10339845/(B)(4)) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). WHEN THE PHYSICIAN WAS GOING TO CONNECT THE THREE WAY STOPCOCK TO THE CLIP INTRODUCER, IT WAS OBSERVED THAT THE CLIP WAS IN AN INVERTED POSITION. THE DECISION WAS MADE TO CONTINUE PREPARATION OF THE DEVICE PER THE IFU, AND THIS SUCCESSFULLY RELAXED THE CLIP. THE CDS WAS ADVANCED INTO THE ANATOMY, TO THE MITRAL VALVE; HOWEVER, WHEN ENTERING THE LEFT VENTRICLE, IT WAS NOT POSSIBLE TO GET INTO THE CORRECT POSITION OF THE JET AREA, DUE TO THE CLIP MOVING MEDIAL, AWAY FROM THE VALVE. THE LEAFLETS WERE NOT ATTEMPTED TO BE GRASPED DUE TO THE STEERING ISSUE OF THE CLIP. THE CLIP WAS NOT DEPLOYED, AND THE CDS WAS REMOVED. A NEW CDS WAS ADVANCED TO THE MITRAL VALVE, BUT THE LEAFLETS COULD NOT BE GRASPED DUE TO THE LEAFLET ANATOMY. THE PROCEDURE WAS ABORTED AND THE MR WAS REDUCED TO 3-4 WITH ONE CLIP IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE. A NEW MITRACLIP PROCEDURE MAY BE PERFORMED FOR THIS PATIENT TO REDUCE THE MR GRADE FURTHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571044 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10339845

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR CONCOMITANT MEDICAL DEVICES