BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 5111450 · Received September 29, 2015

    Report

    Report Number
    2024168-2015-05690
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 4, 2015
    Report Date
    October 12, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. MITRACLIP 50611U129 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS, AND COMPLAINT HISTORY. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED DIFFICULTY GRASPING THE LEAFLETS AND SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WERE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY AND USER TECHNIQUE/PROCEDURAL CIRCUMSTANCES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE, OR LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED BECAUSE THE DEPLOYED CLIP DETACHED FROM ONE MITRAL VALVE LEAFLET, BUT REMAINED ATTACHED TO THE OTHER MITRAL VALVE LEAFLET, WHICH REQUIRED AN ADDITIONAL CLIP FOR TREATMENT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, AND CHALLENGING ANATOMY DUE TO RESTRICTED POSTERIOR LEAFLET AND VERY POOR VISUALIZATION. THE FIRST CLIP (50417U245) HAD DIFFICULTY GRASPING THE LEAFLETS DUE TO THE ANATOMY AND POOR VISUALIZATION; HOWEVER, THE CLIP WAS ABLE TO BE DEPLOYED WITHOUT ISSUE. THE SECOND CLIP (50610U119) HAD DIFFICULTY GRASPING THE LEAFLETS DUE TO THE ANATOMY AND POOR VISUALIZATION; HOWEVER, THE CLIP WAS ABLE TO BE DEPLOYED WITHOUT ISSUE. AFTER CLIP DEPLOYMENT, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS NOTED. IN AN ATTEMPT TO TREAT THE SLDA, IT WAS DECIDED TO DEPLOY A THIRD CLIP. THE THIRD CLIP (50611U129) HAD DIFFICULTY GRASPING THE LEAFLETS DUE TO THE ANATOMY AND POOR VISUALIZATION; HOWEVER, THE CLIP WAS ABLE TO BE DEPLOYED WITHOUT ISSUE. AFTER CLIP DEPLOYMENT, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS NOTED. THE PHYSICIAN BELIEVES THE DIFFICULTY GRASPING AND SLDAS WERE RELATED TO THE RESTRICTED LEAFLET AND POOR VISUALIZATION, NOT DUE TO A DEVICE ISSUE. THE DECISION WAS MADE TO ABORT THE PROCEDURE AT THAT TIME, WITH MR AT 2-3. THE PATIENT REMAINED STABLE DURING THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY; HOWEVER, DUE TO THE PATHOLOGY OF THE LEAFLETS AND THE DIFFICULTIES ENCOUNTERED, NO FUTURE TREATMENT IS CURRENTLY PLANNED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642240 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 50610U119

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention