BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP NTR DELIVERY SYSTEM

    MDR report key: 8664002 · Received June 3, 2019

    Report

    Report Number
    2024168-2019-04324
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    August 23, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER (B)(4). EVALUATION SUMMARY: ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED MECHANICAL ISSUE WAS NOT CONFIRMED DURING RETURN DEVICE ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTE TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND A DEFINITIVE CAUSE FOR THE REPORTED MECHANICAL ISSUE (CLIP OPEN - EFAA) COULD NOT BE DETERMINED IN THIS INCIDENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE 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.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE CLIP OPENED WHILE LOCKED. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE AND GRASPING ACHIEVED. WHILE ESTABLISHING FINAL ARM ANGLE (EFAA), THE CLIP OPENED. EFAA WAS ATTEMPTED TWO MORE TIMES HOWEVER THE CLIP OPENED. THE CLIP WAS NOT IMPLANTED, AND THE CDS WAS REMOVED AND REPLACED. A NEW CDS WAS USED TO COMPLETE THE PROCEDURE. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457269 MITRACLIP NTR DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 90116U273

    Patients

    Seq Age Sex Outcome Treatment
    1 STEERABLE GUIDE CATHETER