BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6158598 · Received December 9, 2016

    Report

    Report Number
    2024168-2016-08744
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 30, 2016
    Report Date
    January 25, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE CLIP DELIVERY SYSTEM WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE DELIVERY CATHETER(DC)SHAFT BEND. IT IS POSSIBLE THAT THERE WERE PROCEDURAL INTERACTIONS (E.G. THE PATIENT ANATOMY AND UNINTENDED CURVES ON THE DEVICE) WHICH RESULTED IN INCREASED STRESS ON THE DEVICE AND THEREFORE CONTRIBUTED TO THE REPORTED BENT DC SHAFT; HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED DIFFICULTY POSITIONING THE DEVICE APPEARS TO BE A SECONDARY EFFECT OF THE DC SHAFT BEND, AND THEREFORE RELATED TO PROCEDURAL CONDITIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS SUBMITTED FOR ATYPICAL STEERING OF THE CLIP DELIVERY SYSTEM (CDS) IN THE ATRIUM. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE REGURGITATION (MR) WITH A GRADE OF 4+. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED THROUGH THE STEERING GUIDE CATHETER WITHOUT RESISTANCE. WHILE STEERING THE CDS TO THE MITRAL VALVE WITH THE M-KNOB, THERE WAS A SET [BEND] IN THE SHAFT CREATING A STEERING ISSUE. THE CLIP WAS NOT IMPLANTED. THE DEVICE WAS REMOVED AND WAS REPLACED WITH A NEW CDS. ONE CLIP WAS IMPLANTED REDUCING THE MR TO 1+. THE PATIENT IS STABLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUS FILED MEDWATCH REPORT FILED, ADDITIONAL INFORMATION RECEIVED: WHILE APPLYING THE M-KNOB, THE SHAFT WAS OVERTURNING DUE TO THE BEND, CAUSING DIFFICULTY POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815592 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60630U155

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR STEERABLE GUIDE CATHETER