BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP

    MDR report key: 20696094 · Received November 15, 2024

    Report

    Report Number
    2135147-2024-05804
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    September 25, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    05415067037398
    PMA / PMN Number
    K190167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED KNOB SLIPPAGE WAS CONFIRMED VIA DEVICE ANALYSIS. ADDITIONALLY, IT WAS OBSERVED THAT THE SGC BRAIDED SHAFT WAS KINKED AND THE SOFT TIP WAS DEFORMED. 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 AVAILABLE INFORMATION, THE INVESTIGATION DETERMINED THE REPORTED KNOB SLIPPAGE TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE CAUSE OF THE OBSERVED KINKED SGC BRAIDED SHAFT AND DEFORMED SOFT TIP WERE UNABLE TO BE DETERMINED. THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXCEPTION AS THE COMPLAINT DESCRIPTION AND DEVICE CODE MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THEREFORE, THIS INCIDENT IS REFERENCING EXCEPTION (ISSUE) 133059 AND EXCEPTION (ACTION) 138821. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND A PROLAPSED POSTERIOR. AFTER INSERTING THE CLIP DELIVERY SYSTEM (CDS) INTO THE STEERABLE GUIDE CATHETER (SGC), A ARGOTIC HUGGER WAS OBSERVED. "+" KNOB WAS ADDED TO ACHIEVE THE DESIRED TRAJECTORY. HOWEVER, IT WAS NOTED THAT THE KNOB WOULD NOT HOLD POSITION. THE PHYSICIAN DECIDED TO TAKE OFF SOME "M" KNOB AND PROCEEDED TO IMPLANT TWO CLIPS, REDUCING MR TO A GRADE OF 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335549 MITRACLIP CATHETER, STEERABLE DRA ABBOTT MEDICAL 40801R2078 05415067037398

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male CLIP DELIVERY SYSTEM