BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4211102 · Received October 29, 2014

    Report

    Report Number
    2024168-2014-07092
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MITRACLIP REMAINS IN THE ANATOMY. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR DEVICE ISSUES REPORTED FOR THIS LOT. POTENTIAL CAUSES FOR PARTIAL CLIP MOVEMENT CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS MORPHOLOGY OF THE MITRAL VALVE, INCLUDING TETHERING OF THE LEAFLETS, CHORDAE INTERACTION, LEAFLETS THAT ARE THINNER/THICKER, RESTRICTED AND PROLAPSED LEAFLETS), USER TECHNIQUE/PROCEDURAL CONDITIONS, DIFFICULTIES WITH VISUALIZATION, OR MANUFACTURING ANOMALIES. IN THIS CASE IT IS LIKELY THE LARGE COAPTATION GAP BETWEEN THE LEAFLETS CONTRIBUTED TO THE DIFFICULTY GRASPING THE LEAFLETS AND THE PARTIAL CLIP MOVEMENT FROM THE ANTERIOR LEAFLET. BASED ON THE INFORMATION REVIEWED, THE REPORTED DIFFICULTY GRASPING LEAFLETS AND PARTIAL CLIP MOVEMENT APPEAR TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED FOR THE PARTIAL CLIP MOVEMENT AND RECURRENT MITRAL REGURGITATION (MR). IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THERE WAS DIFFICULTY GRASPING THE MITRAL VALVE LEAFLETS ON (B)(6) 2014 IN THE PATIENT WITH MIXED ETIOLOGY MR GRADE 4. ONE MITRACLIP WAS DEPLOYED AND THE MR WAS REDUCED FROM TO 3-4 AFTER 4 HOURS AND 45 MINUTES OF DEVICE TIME; THEREFORE, A SECOND CLIP WAS NOT ATTEMPTED THAT DAY. THERE WAS DIFFICULTY GRASPING BOTH LEAFLETS BECAUSE OF THE LARGE COAPTATION GAP BETWEEN THE LEAFLETS. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE DURATION OF THE PROCEDURE. THE PATIENT REMAINED SYMPTOMATIC AFTER THE CLIP PROCEDURE AND PRE-EXISTING SYMPTOMS DID NOT IMPROVE BUT DID NOT WORSEN WITH THE PROCEDURE. THE PATIENT REMAINED IN THE HOSPITAL DUE TO PRE-EXISTING CONDITIONS. ON (B)(6) 2014, THE PATIENT WAS SCHEDULED FOR A SECOND MITRACLIP PROCEDURE. PRE-PROCEDURE ECHOCARDIOGRAM SHOWED THE MR GRADE RETURNED TO 4 DUE TO PARTIAL CLIP MOVEMENT OF THE PREVIOUSLY IMPLANTED CLIP. THE CLIP WAS NOTED TO BE LOOSE ON THE ANTERIOR LEAFLET AND THERE WAS LESS LEAFLET CAPTURED IN THE CLIP. A MITRACLIP DELIVERY SYSTEM (CDS) WAS INSERTED, BUT IT WAS UNABLE TO GRASP BOTH LEAFLETS, THEREFORE, THE CLIP WAS NOT IMPLANTED AND THE CDS WAS REMOVED FROM THE ANATOMY. THE MR WAS UNTREATED AND REMAINED GRADE 4. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691852 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40807U1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R