BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 6654419 · Received June 20, 2017

    Report

    Report Number
    2024168-2017-05200
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 20, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648216800
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE MR ULTIMATELY REMAINED UNCHANGED AS A RESULT OF THE PROCEDURE; HOWEVER, THE REPORTED PATIENT EFFECT OF WORSENING MR, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND A DEFINITIVE CAUSE FOR THE SLDA COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF UNCHANGED MR APPEARS TO BE A RESULT OF PATIENT AND PROCEDURAL CONDITIONS AND DUE TO THE MOVING JET. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING OR LABELING OF THE DEVICE. (B)(4) IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) (70124U193). IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE FIRST CLIP WAS IMPLANTED WITHOUT ISSUES; HOWEVER, MR REMAINED UNCHANGED. CLIP DELIVERY SYSTEM (CDS 70124U173) WAS INSERTED INTO THE STEERABLE GUIDE CATHETER (SGC), RESISTANCE WAS FELT WITH THE SGC, BUT INSERTION WAS SUCCESSFUL. THE CDS WAS ADVANCED INTO THE LEFT ATRIUM. WHILE STEERING WITH THE M-KNOB, THE CDS MOVED IN AN UNINTENDED DIRECTION. THE CLIP WAS NOT IMPLANTED AND THE CDS WAS REPLACED AND THE CLIP IMPLANTED WITH SOME DIFFICULTY, BUT AGAIN MR WAS NOT REDUCED. ANOTHER CLIP (CDS 70124U193) WAS IMPLANTED AND MR REMAINED UNCHANGED; HOWEVER, IT WAS NOTED THAT THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SLDA). BY THE END OF THE PROCEDURE A TOTAL OF 3 CLIPS WERE IMPLANTED. MR REMAINED UNCHANGED AT 4+, DUE TO A MOVING JET. THE PROCEDURE WAS DISCONTINUED. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE PATIENT REMAINED STABLE. VALVE REPLACEMENT MAY BE PERFORMED, BUT HAS NOT BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435560 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 70124U193 08717648216800

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR