BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 22560112 · Received July 21, 2025

    Report

    Report Number
    2135147-2025-03998
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037381
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NA. THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, THE REPORTED UNCHANGED MITRAL VALVE INSUFFICIENCY/ REGURGITATION WAS DUE TO PERFORATION (TISSUE INJURY). HOWEVER, A CAUSE THE REPORTED UNSPECIFIED TISSUE INJURY COULD NOT BE DETERMINED. MITRAL VALVE INSUFFICIENCY/ REGURGITATION AND UNSPECIFIED TISSUE INJURY, LISTED IN THE INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE SPECIFIC CIRCUMSTANCE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR) AND ENDOCARDITIS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP XTW (50123R104) WAS CHOSEN FOR A IMPLANTATION. AN ATTEMPT WAS MADE TO PLACE THE CLIP LATERALLY BUT THE MR REMAINED UNCHANGED. ANOTHER XTW (50123R1041) WAS PLACED MEDIALLY, BUT MR REMAINED UNCHANGED. AFTER FURTHER INVESTIGATION, THEY NOTED A SMALL PERFORATION ON THE ARTERIAL LEAFLET NEAR TO THE FIRST LATERAL CLIP. . AS PER THE PHYSICIAN, THE MR REMAINED UNCHANGED DUE TO PERFORATION. THE PATIENT WAS TRANSFERRED TO BOSTON HOSPITAL FOR EXTUBATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR) AND ENDOCARDITIS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP XTW (50123R104) WAS CHOSEN FOR A IMPLANTATION. AN ATTEMPT WAS MADE TO PLACE THE CLIP LATERALLY BUT THE MR REMAINED UNCHANGED. ANOTHER XTW (50123R1041) WAS PLACED MEDIALLY, BUT MR REMAINED UNCHANGED. AFTER FURTHER INVESTIGATION, THEY NOTED A SMALL PERFORATION ON THE ARTERIAL LEAFLET NEAR TO THE FIRST LATERAL CLIP. AS PER THE PHYSICIAN, THE MR REMAINED UNCHANGED DUE TO PERFORATION. THE PATIENT WAS TRANSFERRED TO (B)(6) FOR EXTUBATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035850 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0706-XTW 50123R1041 05415067037381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O STEERABLE GUIDE CATHETER