BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP

    MDR report key: 20373967 · Received October 4, 2024

    Report

    Report Number
    2135147-2024-04903
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    08717648288654
    PMA / PMN Number
    K190167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED UNINTENDED MOVEMENT ASSOCIATED WITH KNOB SLIPPAGE WAS CONFIRMED VIA DEVICE 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 INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED KNOB SLIPPAGE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE APPEARS TO BE RELATED TO AN OPEN TREND EXCEPTION (REFERENCE EXCEPTION (ISSUE) 133059). THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED. HOWEVER, INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION WITH A GRADE OF 4. IT WAS NOTED, WHILE APPLYING THE + KNOB, THE KNOB WOULD RETURN TO A NEUTRAL POSITION OVER TIME. THE PHYSICIAN DECIDED TO USE A CLOTH TAPE TO HOLD THE KNOB IN POSITION AND CONTINUE WITH THE PROCEDURE. ONE CLIP WAS THEN IMPLANTED, REDUCING MR TO A GRADE OF 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704422 MITRACLIP CATHETER, STEERABLE DRA ABBOTT MEDICAL 40513R1116 08717648288654

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention CLIP DELIVERY SYSTEM