BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 6132773 · Received November 29, 2016

    Report

    Report Number
    2024168-2016-08394
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 29, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648216800
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. THE REPORTED PATIENT EFFECT OF MITRAL VALVE INJURY (TISSUE DAMAGE), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED DIFFICULTY GRASPING APPEARS TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY. IT IS POSSIBLE THAT THERE WERE PROCEDURAL INTERACTIONS (E.G. THE PATIENT ANATOMY AND UNINTENDED CURVES ON THE DEVICE) WHICH RESULTED IN INCREASED TENSION ON THE DEVICE AND THEREFORE CONTRIBUTED TO THE DIFFICULTY CLOSING THE CLIP; HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED POTENTIAL LEAFLET TEAR (TISSUE DAMAGE) WAS LIKELY A RESULT OF PROCEDURAL CONDITIONS AND POTENTIALLY DUE TO THE DIFFICULTIES IN GRASPING WITH THE CLIP. THE REPORTED SURGICAL PROCEDURE AND PROLONGED HOSPITALIZATION WERE A RESULT OF CASE SPECIFIC CIRCUMSTANCES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING, OR LABELING OF THE DEVICE. THE STEERABLE GUIDE CATHETER REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS WILL BE CONSERVATIVELY FILED FOR POSSIBLE A LEAFLET TEAR DURING THE PROCEDURE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE STEERABLE GUIDING CATHETER (SGC) AND THE CLIP DELIVERY SYSTEM (CDS) WERE ADVANCED TO THE RIGHT ATRIUM. DUE TO CHALLENGING ANATOMY, THERE WAS DIFFICULTY GRASPING THE MITRAL VALVE LEAFLETS AND MULTIPLE ATTEMPTS WERE PERFORMED. WHEN CLOSING THE CLIP TO 100 DEGREES, THE CLIP BARELY CLOSED. UPON FURTHER CLOSING THE CLIP, MR WAS REDUCED TO 1-2. HOWEVER, ONCE THE CLIP WAS COMPLETELY CLOSED; MR RETURNED TO 4+. IT IS UNKNOWN WHY MR RETURNED TO 4+. POSSIBLE LEAFLET TEAR OCCURRED BUT COULD NOT BE CONFIRMED DUE TO DIFFICULT VISUALIZATION DUE TO ANATOMY. THE CLIP WAS NOT DEPLOYED AND THE PROCEDURE WAS DISCONTINUED WITH NO CLIPS IMPLANTED. IT WAS ALSO NOTED THAT THE (IATROGENIC) ATRIAL SEPTAL DEFECT WAS ENLARGED BY 4MM. ON (B)(6) 2016, SURGICAL MITRAL VALVE REPLACEMENT AND REPAIR OF THE ENLARGED ATRIAL SEPTAL DEFECT WAS PERFORMED. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781905 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60919U102 08717648216800

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R| S STEERABLE GUIDE CATHETER