BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP

    MDR report key: 20340483 · Received September 30, 2024

    Report

    Report Number
    2135147-2024-04809
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648288616
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE RETURNED DEVICE ANALYSIS CONFIRMED THE REPORTED INABILITY TO OPEN THE CLIP. ADDITIONALLY, IT WAS OBSERVED THAT THE LOCK LINE WAS TIED (MATERIAL DEFORMATION) AROUND THE L-LOCK SHAFT. BASED ON THE INFORMATION REVIEWED AND THE ANALYSIS OF THE RETURNED DEVICE, THE REPORTED INABILITY TO OPEN THE CLIP APPEARS TO BE RELATED TO THE LOCK LINE TIED AROUND THE L-LOCK SHAFT. THE REPORTED MATERIAL DEFORMATION (TIED LOCK LINE) APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE; THEREFORE, THIS COMPLAINT WAS INITIATED AN EXCEPTION (ISSUE) 132935 TO EVALUATE WHETHER A PRODUCT ISSUE EXISTS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION, THE CLIP WAS UNABLE TO OPEN. THEREFORE, THE CLIP WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS REVEALED THE LOCK LINE (LL) WAS WRAPPED AROUND THE L-LOCK SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39733 MITRACLIP MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40130R1066 08717648288616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown