BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 6199865 · Received December 22, 2016

    Report

    Report Number
    2024168-2016-09157
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 1, 2016
    Report Date
    January 24, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CLIP DELIVERY SYSTEM IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CLIP DELIVERY SYSTEM (CDS) WAS RECEIVED AND INVESTIGATED. THE REPORTED INABILITY TO REMOVE THE GRIPPER LINE WAS NOT CONFIRMED AS THE GRIPPER LINE WAS NOT RETURNED WITH THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE PATIENT EFFECT OF FAILURE TO RETRIEVE MITRACLIP SYSTEM COMPONENTS (FOREIGN BODY LEFT IN PATIENT), AS LISTED IN THE 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 REPORTED INABILITY TO REMOVE THE GRIPPER LINE IN THIS INCIDENT COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE USER TECHNIQUE OF REMOVING THE GRIPPER LINE CONTRIBUTED TO THE USER EXPERIENCE AS IT WAS REPORTED THAT NO ISSUES WERE OBSERVED DURING PREPARATION AND FUNCTIONAL TESTING OF THE DEVICE AND THE GRIPPER LINE REMOVABILITY WAS ESTABLISHED SUCCESSFULLY; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE STEERABLE GUIDE CATHETER REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THAT THE GRIPPER LINE COULD NOT BE REMOVED AND WAS LEFT IN THE ANATOMY, ATTACHED TO THE DEPLOYED CLIP, WHICH IS CONSIDERED A SERIOUS INJURY TO THE PATIENT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THERE WAS A LARGE JET LOCATED ALONG THE A2-P2 AND A1-P1 SCALLOP. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE LEAFLETS AND THE MR WAS REDUCED TO 3+ WITH GRASPING. DEPLOYMENT STEPS WERE STARTED, BUT AFTER THE GRIPPER LINE WAS RETRACTED A FEW MILLIMETERS, IT COULD NOT BE PROPERLY REMOVED. IT WAS CONFIRMED THAT THE GRIPPER LINE MOVED FREELY DURING THE GRIPPER LINE REMOVABILITY TEST. TROUBLESHOOTING MANEUVERS WERE PERFORMED WITHOUT SUCCESS. THE CDS WAS REMOVED, LEAVING THE GRIPPER LINE IN PLACE. AFTER REMOVING THE CDS, THE TWO ENDS OF THE GRIPPER LINE WERE VISIBLE OUTSIDE THE HEMOSTATIC VALVE OF THE SGC. ANOTHER ATTEMPT WAS MADE TO REMOVE THE GRIPPER LINE, BUT WAS UNSUCCESSFUL. THE SGC WAS THEN REMOVED, LEAVING THE GRIPPER LINE IN PLACE ATTACHED TO THE DEPLOYED CLIP. A NEW SGC WAS ADVANCED A SECOND CLIP (60811U156) WAS DEPLOYED LATERAL TO THE FIRST CLIP, REDUCING THE MR TO 1-2. THE PATIENT WAS CONFIRMED TO BE STABLE POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847624 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60921U136

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER