BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3943778 · Received July 18, 2014

    Report

    Report Number
    2024168-2014-04622
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 9, 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). THE MITRACLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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 EVENT 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 HISTORY OF THE REPORTED LOT FOUND NO SIMILAR INCIDENTS FOR PARTIAL CLIP MOVEMENT. POTENTIAL CAUSES FOR FAILURE TO ADHERE OR BOND TO THE LEAFLETS (PARTIAL CLIP MOVEMENT) 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. WITH RESPECT TO THE PATIENT CONDITIONS, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE DIFFICULTY IN GRASPING BOTH LEAFLETS 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 PATIENT EFFECTS OF DYSPNEA, WORSENING MITRAL REGURGITATION (MR) AND HEART FAILURE ARE LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. IT WAS REPORTED THAT THE INCREASED MR SEEMED TO BE CAUSED BY THE PROGRESSION OF THE DILATATION OF THE HEART, WHICH ALSO SEEMED TO CAUSE THE ANTERIOR MITRAL VALVE LEAFLET (AML) TO BE PARTIALLY TORN OUT OF THE CLIP. BASED ON THE INFORMATION REVIEWED, THE PARTIAL CLIP MOVEMENT APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS, AS PROGRESSION OF THE DILATION OF THE HEART CAUSED THE ANTERIOR LEAFLET TO BE PARTIALLY REMOVED FROM THE CLIP. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS THE CLIP WAS FULLY ATTACHED TO THE POSTERIOR LEAFLET BUT ONLY PARTIALLY ATTACHED TO THE ANTERIOR LEAFLET, WHICH CONTRIBUTED TO THE INCREASED MITRAL REGURGITATION GRADE. ANOTHER MITRACLIP PROCEDURE WAS PERFORMED AND IS CONSIDERED MEDICAL INTERVENTION. IT WAS REPORTED THAT ON (B)(6) 2012 A MITRACLIP PROCEDURE WAS PERFORMED. ONE CLIP (10163730/04) WAS IMPLANTED REDUCING THE FUNCTIONAL MITRAL REGURGITATION (MR) GRADE FROM 3 TO LESS THAN 1. ON (B)(6) 2014, THE PATIENT EXPERIENCED SHORTNESS OF BREATH, AN INCREASE IN THE (B)(6) CLASS TO III-IV AND THE MR GRADE INCREASED TO 4. THE CLIP WAS ONLY PARTIALLY ATTACHED TO THE ANTERIOR MITRAL VALVE LEAFLET (AML) AND WAS FULLY ATTACHED TO THE POSTERIOR LEAFLET. NO DAMAGE TO THE ANTERIOR LEAFLET WAS VISIBLE IN THE ECHOCARDIOGRAM. THE INCREASED MR SEEMED TO BE CAUSED BY THE PROGRESSION OF THE DILATATION OF THE HEART AND THE MOVEMENT OF THE CLIP ON THE AML. ON (B)(6) 2014, A SECOND MITRACLIP PROCEDURE WAS PERFORMED. ONE CLIP WAS IMPLANTED REDUCING THE MR TO 3. ADDITIONAL CLIPS WERE NOT ABLE TO BE IMPLANTED DUE TO A HIGH PRESSURE GRADIENT AND THE CONCERN OF MITRAL STENOSIS. ALL DEVICES WORKED AS EXPECTED; THERE WAS NO ALLEGATION AGAINST THE ABBOTT DEVICES BY THE PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422012 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10163730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R