BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4203739 · Received October 27, 2014

    Report

    Report Number
    2024168-2014-07008
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 2, 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). DATE OF EVENT ESTIMATED (REPORTED AS (B)(6) 2014). 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. 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 SLDA (SINGLE LEAFLET DEVICE ATTACHMENT-DEPLOYED CLIP DETACHED FROM ONE MITRAL VALVE LEAFLET, BUT REMAINED ATTACHED TO THE OTHER MITRAL VALVE LEAFLET) 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 PERFORM LEAFLET ASSESSMENT) OR MANUFACTURING ANOMALIES. WITH RESPECT TO THE PATIENT CONDITIONS, 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. BASED ON THE INFORMATION REVIEWED, THE REPORTED SLDA APPEARS TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS, AS THE PROGRESSION OF THE DISEASE RESULTED IN A POSTERIOR LEAFLET PROLAPSE, CONTRIBUTING TO THE REPORTED SLDA. THE PATIENT EFFECTS OF DYSPNEA, ATRIAL FIBRILLATION, AND WORSENING MR 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR SLDA INCIDENTS REPORTED FOR THIS LOT. 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 IMPLANTED CLIP DETACHED FROM ONE MITRAL VALVE LEAFLET AND REMAINED ATTACHED TO THE OTHER LEAFLET. AN ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED WHICH IS CONSIDERED MEDICAL INTERVENTION. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2013 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED AND THE MR WAS REDUCED TO 2. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT PRESENTED WITH DYSPNEA AND PAROXYSMAL ATRIAL FIBRILLATION. A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED WHICH FOUND THAT THE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET, AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT). THE MR GRADE HAD INCREASED TO 4 AND THERE WAS A POSTERIOR LEAFLET PROLAPSE DUE TO THE DISEASE. AN ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2014. TWO CLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 2. THE PATIENT WAS CLINICALLY STABLE POST-PROCEDURE AND 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
    683317 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10253815

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R