BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15852218 · Received November 23, 2022

    Report

    Report Number
    2135147-2022-02196
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 10, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648231001
    PMA / PMN Number
    P100009
    Removal / Correction Number
    2024168-9/6/2022-003-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) APPEARS TO BE DUE TO CHALLENGING ANATOMY (THIN LEAFLET). THE REPORTED POOR IMAGE RESOLUTION WAS DIFFICULT TO VISUALIZE DUE TO IT BEING A TRICUSPID VALVE CASE. IT SHOULD BE NOTED THAT THE MITRACLIP G4 SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: ¿THE MITRACLIP¿ G4 SYSTEM IS INDICATED FOR THE PERCUTANEOUS REDUCTION OF SIGNIFICANT SYMPTOMATIC MITRAL REGURGITATION (MR). SINCE THE MITRACLIP DEVICE WAS IMPLANTED ON A TRICUSPID VALVE, THIS IS CONSIDERED AS AN OFF-LABEL USE OF THE DEVICE. HOWEVER, THE OFF-LABEL USE OF THE DEVICE DID NOT CONTRIBUTED TO THE REPORTED SLDA. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS THE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (FTR) GRADE 4 WITH THIN LEAFLETS. TO TREAT THE TR, A MITRACLIP XTW WAS DEPLOYED IN THE TRICUSPID VALVE. HOWEVER, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED ON THE POSTERIOR LEAFLET. IT WAS NOTED THAT THE SLDA WAS LIKELY DUE TO THE THIN LEAFLETS. IMAGING WAS NOTED TO BE CHALLENGING DUE TO THE PROCEDURE BEING A TRICUSPID REGURGITATION CASE. TWO ADDITIONAL CLIPS WERE DEPLOYED TO STABILIZE THE SLDA CLIP, AND THE PROCEDURE WAS COMPLETED. THE TR 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
    239829 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0701-XTW 20901R1072 08717648231001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention