BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 18862519 · Received March 7, 2024

    Report

    Report Number
    2135147-2024-01052
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 14, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648231018
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED LEAK WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS AND OBSERVED THE DC HANDLE BODY SEAL TO BE DAMAGED AND NOT PROPERLY SEATED INSIDE THE SLOT OF THE HANDLE BODY; THEREFORE, EXCEPTION (ISSUE) 131124 WAS INITIATED ON (B)(6)2024 TO EVALUATE WHETHER A PRODUCT ISSUE EXISTS. 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. THE INVESTIGATION DETERMINED THE REPORTED LEAK APPEARS TO BE RELATED TO THE IDENTIFIED DAMAGED HANDLE BODY SEAL AND SEAL NOT PROPERLY SEATED IN THE HANDLE BODY. THE DAMAGED SEAL AND SEAL NOT PROPERLY SEATED IN THE HANDLE BODY APPEAR TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. 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. THE ADDITIONAL MITRACLIP DEVICE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. NA.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND ROTATED HEART. DURING PREPARATION OF AN XTW CLIP (31012R2114), A LEAK WAS OBSERVED AT THE FLUSH PORT ON THE DELIVERY CATHETER (DC). THEREFORE, THE CLIP DELIVERY SYSTEM (CDS) WAS NOT USED AND WAS REPLACED. AN XTW CLIP (31017R1086) WAS INSERTED AND ADVANCED TO THE MITRAL VALVE, BUT THE CLIP BECAME CAUGHT IN CHORDAE AND THE LEAFLETS WERE CAUGHT ON THE GRIPPERS. TROUBLESHOOTING WAS PERFORMED AND THE CLIP WAS SUCCESSFULLY FREED FROM THE CHORDAE AND LEAFLETS. THE CLIP ABLE TO BE DEPLOYED ON THE MITRAL VALVE, BUT A CHORDAL RUPTURE WAS OBSERVED. TO FURTHER REDUCE MR, AN NTW CLIP (30620R1020) WAS INSERTED, AND GRASPING ATTEMPTS WERE PERFORMED. HOWEVER, DIFFICULTIES GRASPING AND CAPTURING THE LEAFLETS OCCURRED RESULTING IN AN ADDITIONAL CHORDAL RUPTURE; THEREFORE, THE CLIP WAS REMOVED AND THE PROCEDURE WAS DISCONTINUED. MR REMAINED AT A GRADE OF 4 AND AN IMPELLA HEART PUMP WAS IMPLANTED. IT WAS NOTED THE PATIENT EFFECTS RESULTED IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162823 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 31012R2114 08717648231018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown