BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP XTR DELIVERY SYSTEM

    MDR report key: 8704766 · Received June 17, 2019

    Report

    Report Number
    2024168-2019-04751
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 27, 2019
    Report Date
    August 19, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER: (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 REPORTED EVEN. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO LOT-SPECIFIC PRODUCT QUALITY ISSUE FROM THIS LOT. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED SLDA APPEARS TO BE RELATED TO CHALLENGING PATIENT ANATOMY/MORPHOLOGY. 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. CONCOMITANT MEDICAL PRODUCTS: STEERABLE GUIDE CATHETER, MITRACLIP NTR DELIVERY SYSTEM. THE CLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE MITRACLIP NTR (90218U164) REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE MITRACLIP XTR DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 WITH CALCIFICATION ON A2 AND A RESTRICTIVE POSTERIOR LEAFLET. A MITRACLIP XTR WAS ADVANCED AND SUCCESSFULLY IMPLANTED MEDIAL TO THE A2/P2 POSITION. A MITRACLIP NTR (90218U164) WAS ADVANCED, HOWEVER GRASPING WAS NOT ATTEMPTED AS THE PATH OF THE CLIP WAS INCORRECT. THE CLIP WAS INVERTED AND RETRACTED FROM THE LEFT VENTRICLE TOWARDS THE LEFT ATRIUM, UPON WHICH THE MITRACLIP XTR CLIP WAS NOTED TO BE DETACHED FROM THE ANTERIOR LEAFLET; A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED. THE MITRACLIP NTR CLIP WAS SUBSEQUENTLY IMPLANTED AT THE A2/P2 POSITION. A SECOND MITRACLIP NTR WAS ADVANCED TO FURTHER REDUCE MR AND WAS DEPLOYED LATERAL TO THE FIRST MITRACLIP NTR CLIP. 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
    498229 MITRACLIP XTR DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 90211U174

    Patients

    Seq Age Sex Outcome Treatment
    1