BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP NTR DELIVERY SYSTEM

    MDR report key: 8663170 · Received June 3, 2019

    Report

    Report Number
    2024168-2019-04300
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 9, 2019
    Report Date
    June 3, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648226342
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT THE PATIENT ANATOMY (DEGENERATIVE LEAFLET, BIG PROLAPSE) CONTRIBUTED TO THE REPORTED SLDA. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL MITRACLIP DEVICE IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS IS FILED AS THE CLIP ((CDS0601-NTR/81004U226)) DETACHED FROM ONE LEAFLET AND REMAINED ATTACHED TO THE OTHER LEAFLET. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2018, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS WERE SUCCESSFULLY IMPLANTED REDUCING MR TO 1-2. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH AN INCREASE IN MR TO 4. BOTH MITRACLIPS REMAINED STABLE ON BOTH LEAFLETS. ON (B)(6) 2019, A SECOND MITRACLIP PROCEDURE WAS PERFORMED. ONE MITRACLIP NTR WAS SUCCESSFULLY IMPLANTED. A SECOND MITRACLIP NTR (CDS0601-NTR/81004U226) WAS ADVANCED AND IMPLANTED MEDIAL TO THE THREE CLIPS, HOWEVER A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED. THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET. POST PROCEDURE MR WAS REDUCED TO 2. 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
    455120 MITRACLIP NTR DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 81004U226 08717648226342

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR