BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3884969 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03959
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MITRACLIP REMAINS IMPLANTED ON THE ANTERIOR MITRAL VALVE LEAFLET. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY AND INFORMATION PROVIDED TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR SINGLE LEAFLET DEVICE ATTACHMENT (SLDA - DEPLOYED CLIP DETACHED FROM ONE MITRAL VALVE LEAFLET, BUT REMAINED ATTACHED TO THE OTHER MITRAL VALVE LEAFLET) LEADING TO INCOMPLETE COAPTATION OF THE LEAFLETS 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. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP AND ITS INNER COMPONENTS ACTUATED AS EXPECTED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE USER ALSO REPORTED NO ISSUES WHILE FUNCTIONALLY INSPECTING THE CLIP DELIVERY SYSTEM DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY. THERE IS NO INDICATION THAT THE MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, 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. THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT THERE WERE NO PROBLEMS WITH VISUALIZATION OR IMPLANTATION OF THE CLIPS, AND THE SECOND CLIP DID NOT COME INTO CONTACT WITH THE FIRST IMPLANTED CLIP. IT WAS NOTED THAT THERE WAS TETHERING OF THE POSTERIOR LEAFLET AND TEE CONFIRMED THAT THE POSTERIOR LEAFLET HAD DETACHED FROM THE CLIP. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA APPEARS TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS, AS THE PATIENTS TETHERING POSTERIOR LEAFLET LIKELY CONTRIBUTED TO THE CLIP DETACHMENT. IN THIS CASE, THE MOST PROBABLE CAUSE FOR THE INCREASE IN MITRAL REGURGITATION (MR) WAS DUE TO THE DETACHMENT OF THE CLIP (SLDA). THE PATIENT EFFECT OF MR (WORSENING) IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED ADDITIONAL THERAPY/NON-SURGICAL TREATMENT AND HOSPITALIZATION WERE RELATED TO CASE-SPECIFIC CIRCUMSTANCES, AS THE PATIENTS HOSPITALIZATION WAS EXTENDED AND A SECOND MITRACLIP PROCEDURE WAS PERFORMED BY PLACING TWO ADDITIONAL CLIPS TO REDUCE THE MR. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED AS THE CLIP (10299825/(B)(4)) DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THE MITRAL REGURGITATION (MR) INCREASED WHICH RESULTED IN ANOTHER MITRACLIP PROCEDURE AND IS CONSIDERED MEDICAL INTERVENTION. IT WAS REPORTED THAT ON (B)(6) 2014, A MITRACLIP PROCEDURE WAS PERFORMED AND TWO CLIPS WERE IMPLANTED REDUCING THE FUNCTIONAL MR GRADE FROM 4 TO 2-3. DURING THE PROCEDURE, THERE WAS NO DIFFICULTY VISUALIZING OR IMPLANTING THE CLIPS. THE PHYSICIAN PERFORMED TWO GRASPING ATTEMPTS WITH THE FIRST CLIP. THE SECOND CLIP DID NOT COME IN CONTACT WITH THE FIRST IMPLANTED CLIP. THERE WAS TETHERING OF THE POSTERIOR LEAFLET, BUT THE LENGTH OF THE LEAFLET WAS GREATER THAN 1CM. ON (B)(6) 2014, DURING A TRANSTHORACIC ECHOCARDIOGRAM, A POSSIBLE PARTIAL DETACHMENT OF THE POSTERIOR LEAFLET FROM THE FIRST CLIP (10299825/(B)(4)) THAT WAS IMPLANTED WAS OBSERVED. A TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED THAT THE POSTERIOR LEAFLET HAD DETACHED FROM THE CLIP AND THE MR GRADE INCREASED TO 3-4. THE PATIENT'S HOSPITALIZATION HAD BEEN EXTENDED TO THE POSTERIOR CLIP DETACHMENT AND INCREASED MR. THE PATIENT WAS CLINICALLY STABLE. ON (B)(6) 2014, THE PATIENT UNDERWENT A SECOND MITRACLIP PROCEDURE AND TWO CLIPS WERE IMPLANTED REDUCING THE MR GRADE TO 2+. POST PROCEDURE THE PATIENT WAS CLINICALLY STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361970 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10299825

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MITRACLIP (X1)