BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 20322456 · Received September 27, 2024

    Report

    Report Number
    2135147-2024-04773
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 18, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037435
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED GRIPPER ACTUATION ISSUE WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE GRIPPER ACTUATION ISSUE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE; THEREFORE, THIS COMPLAINT WAS ADDED TO EXCEPTION (ACTION) 138503, (ISSUE) 132833 ON 20-SEP-2024 TO EVALUATE WHETHER A PRODUCT QUALITY 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 DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED GRIPPER ACTUATION ISSUE APPEARS 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.

    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 FLAIL. DURING THE PREPARATION, ONE OF THE GRIPPERS FOR AN NTW CLIP (40207A1013) DID NOT LOWER. THEREFORE, THE CLIP WAS NOT USED AND WAS REPLACED. ONE CLIP WAS THEN IMPLANTED. TO FURTHER REDUCE MR, AN ADDITIONAL NTW CLIP (40229A1016) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND HAD NO ISSUES DURING PREP. HOWEVER, WHEN THE CLIP WAS INSERTED INTO THE LEFT ATRIUM (LA), IT WAS UNABLE TO OPEN. TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS STILL UNABLE TO OPEN. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. ONE CLIP WAS THEN IMPLANTED, REDUCING MR TO A GRADE OF 3. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    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 FLAIL. DURING THE PREPARATION, ONE OF THE GRIPPERS FOR AN NTW CLIP (40207A1013) DID NOT LOWER. THEREFORE, THE CLIP WAS NOT USED AND WAS REPLACED. ONE CLIP WAS THEN IMPLANTED. TO FURTHER REDUCE MR, AN ADDITIONAL NTW CLIP (40229A1016) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND HAD NO ISSUES DURING PREP. HOWEVER, WHEN THE CLIP WAS INSERTED INTO THE LEFT ATRIUM (LA), IT WAS UNABLE TO OPEN. TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS STILL UNABLE TO OPEN. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. ONE CLIP WAS THEN IMPLANTED, REDUCING MR TO A GRADE OF 3. 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
    1432915 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40207A1013 05415067037435

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male STEERABLE GUIDE CATHETER