BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 19060532 · Received April 8, 2024

    Report

    Report Number
    2135147-2024-01585
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037367
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED CRACKED AND BROKEN FLUSH PORT LUER WERE CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE REPORTED LEAK COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. 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 AND THE RETURNED DEVICE ANALYSIS, THE REPORTED LEAK APPEARS TO BE A CASCADING EVENT OF THE REPORTED CRACKED FLUSH PORT. THE BROKEN FLUSH PORT APPEARS TO BE RELATED TO POST-PROCEDURAL HANDLING AS THE FLUSH PORT BROKE WHEN UNSCREWING THE STOPCOCK. THE INVESTIGATION DETERMINED THE REPORTED CRACKED FLUSH PORT LUER TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXCEPTION ESCALATION AS THE COMPLAINT DESCRIPTION AND DEVICE CODE MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THEREFORE, EXCEPTION (ISSUE) 127621 AND EXCEPTION (ACTION) 132488 ARE REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE POTENTIAL ROOT CAUSE TO BE MOTHER NATURE IN THE FORM OF ENVIRONMENTAL STRESS CRACKING (ESC). 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 THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS SUCCESSFULLY IMPLANTED. TO FURTHER REDUCE MR, AN ADDITIONAL CLIP WAS INSERTED. DURING THE START OF THE DEPLOYMENT STEPS, IT WAS OBSERVED A LEAK WAS PRESENT ON THE CLIP INTRODUCER. THE PHYSICIAN DECIDED TO PROCEED WITH DEPLOYING THE CLIP. THE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR TO A GRADE OF 1-2. AFTER THE PROCEDURE, IT WAS OBSERVED THAT THERE WAS A CRACK ON THE FLUSH PORT OF THE CLIP INTRODUCER. WHEN UNSCREWING THE STOPCOCK, PART OF THE FLUSH PORT DETACHED FROM THE INTRODUCER. 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
    103640 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 30911R1107 05415067037367

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female IMPLANTED MITRACLIP.| STEERABLE GUIDE CATHETER.