BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4141087 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06430
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT-HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FOR THE REPORTED INCOMPLETE COAPTATION/SLDA FROM THIS LOT. THE REPORTED PATIENT EFFECTS OF TISSUE DAMAGE (MITRAL VALVE INJURY) AND ATRIAL PERFORATION (ATRIAL SEPTAL DEFECT) AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. POTENTIAL CAUSES FOR SLDA LEADING TO INCOMPLETE COAPTATION CAN INCLUDE, BUT ARE 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 GRASP THE LEAFLETS) OR MANUFACTURING ANOMALIES. THE SLDA 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. IN THIS CASE, THE INFORMATION PROVIDED STATED THAT THERE WAS SOME DIFFICULTY WITH VISUALIZATION DURING LEAFLET ASSESSMENT AS ONE CLIP WAS ALREADY IMPLANTED; HOWEVER, THE LEAFLET ASSESSMENT WAS CONFIRMED. IT WAS FURTHER STATED THAT THE ANTERIOR LEAFLET WAS PROLAPSED AND THE PATIENT HAD A BIG HEART. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA LEADING TO INCOMPLETE COAPTATION APPEARS TO BE RELATED TO PROCEDURAL / PATIENT CONDITIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED FOR THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA - THE DEPLOYED CLIP DETACHED FROM ONE MITRAL VALVE LEAFLET, BUT REMAINED ATTACHED TO THE OTHER MITRAL VALVE LEAFLET). IT WAS REPORTED THAT THIS WAS MITRACLIP PROCEDURE TO TREAT MIXED ETIOLOGY MITRAL REGURGITATION (MR) GRADE 4, WITH POSTERIOR LEAFLET PROLAPSE. THE POSTERIOR LEAFLET WAS SLIGHTLY RESTRICTED MOSTLY IN P3 AND P2 REGION. THE FIRST MITRACLIP WAS IMPLANTED REDUCING THE MR FROM 4 TO 2-3. THERE WAS SOME DIFFICULTY WITH VISUALIZATION, AS ONE CLIP WAS ALREADY IMPLANTED, BUT THE SECOND MITRACLIP WAS INSERTED IN THE LEAFLET AND LEAFLET ASSESSMENT WAS CONFIRMED. THE SECOND MITRACLIP WAS DEPLOYED AND THE MR WAS FURTHER REDUCED TO 1-2. THERE WAS AN SLDA WITH THE SECOND MITRACLIP (THE DEPLOYED CLIP DETACHED FROM ONE MITRAL VALVE LEAFLET, BUT REMAINED ATTACHED TO THE OTHER MITRAL VALVE LEAFLET). MR INCREASED TO 3. LEAFLET FLAIL AND CHORD RUPTURE ON THE ANTERIOR LEAFLET WAS NOTICED AFTER THE SLDA. A THIRD MITRACLIP WAS IMPLANTED TO STABILIZE THE SLDA CLIP AND REDUCE THE MR FROM 4 TO 2. AT THE 48 HOUR ECHOCARDIOGRAM WHEN FLUID STATUS WAS NORMALIZED; MR WAS 1-2. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618342 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40513U1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention STEERABLE GUIDE CATHETER, 1ST IMPLANTED MITRACLIP