BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3790966 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02828
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 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). CONCOMITANT PRODUCTS: GUIDE CATHETER: GUIDELINER; MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER, CLIP DELIVERY SYSTEM. THE MITRACLIP REMAINS IN THE ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL MITRACLIP (10319755/(B)(4)) REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. POTENTIAL CAUSES FOR SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) LEADING TO INCOMPLETE COAPTATION CAN INCLUDE, BUT ARE 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). WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE SLDA AND DEVICE DAMAGED BY ANOTHER 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 INTERACTION BETWEEN THE TWO CLIPS MOST LIKELY INADVERTENTLY DISLODGED THE PREVIOUSLY IMPLANTED CLIP FROM THE POSTERIOR LEAFLET (DEVICE DAMAGED BY ANOTHER) RESULTING IN THE SLDA. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA AND DEVICE DAMAGED BY ANOTHER DEVICE APPEAR TO BE RELATED TO PROCEDURAL CONDITIONS AND NOT A PRODUCT QUALITY DEFICIENCY. IT WAS FURTHER REPORTED THAT THE MITRAL REGURGITATION (MR) GRADE INCREASED FOLLOWING THE SLDA. THE MOST PROBABLE CAUSE OF MR WAS LIKELY DUE TO THE SLDA. THE REPORTED PATIENT EFFECT OF MR IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO SIMILAR INCIDENTS REPORTED FOR INCOMPLETE COAPTATION AND DEVICE DAMAGED BY ANOTHER FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS REPORT IS SUBMITTED TO CAPTURE THE CLIP DETACHMENT FROM THE POSTERIOR LEAFLET WHICH OCCURRED WITH THE CLIP (10292485/(B)(4)), AND REQUIRED MEDICAL INTERVENTION TO PREVENT PATIENT INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4. THE FIRST CLIP (10292485/(B)(4)) WAS IMPLANTED, AND THE MR GRADE WAS REDUCED TO 1-2. THE SECOND CLIP (10319755/(B)(4)) WAS ADVANCED WITHOUT ISSUE. DURING PLACEMENT OF THE SECOND CLIP, THE FIRST CLIP DETACHED FROM THE POSTERIOR LEAFLET. IT IS BELIEVED THAT THE SECOND CLIP CAME IN CONTACT WITH THE FIRST CLIP, CAUSING THE DETACHMENT, BUT NO RESISTANCE WAS NOTED. THE MR GRADE RETURNED TO 3-4. THE SECOND CLIP WAS MANAGED TO BE PLACED VERY CLOSELY LATERAL OF THE DETACHED CLIP, AND THE MR WAS REDUCED TO 2. IT WAS NOTED THAT IT TOOK A LITTLE LONGER TO VISUALIZE THE CLIPS DURING IMPLANTATION DUE TO THE LACK OF EXPERIENCE OF THE ECHOCARDIOGRAPHER. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE. 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
    266661 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10292485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES