BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 24282789 · Received February 6, 2026

    Report

    Report Number
    2135147-2026-00714
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 19, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067050755
    PMA / PMN Number
    P100009
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE RETURNED DEVICE ANALYSIS CONFIRMED THE REPORTED MECHANICAL JAM ASSOCIATED WITH THE LKV RELEASE SLIDER. ADDITIONALLY, IT WAS OBSERVED THAT THE LKV INSERT WAS ASSEMBLED REVERSED AS THE MARKS AND THE TAB OF THE LKV INSERT WERE ON THE OPPOSITE SIDE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS FROM THE LOT. ALL INFORMATION WAS INVESTIGATED AND BASED ON THE INFORMATION PROVIDED AND THE RETURNED DEVICE ANALYSIS, THE REPORTED LKV RELEASE SLIDER JAM AND THE OBSERVED LKV INSERT ASSEMBLED IN A REVERSED ORIENTATION 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. ADDITIONALLY, A CAUSE FOR THE REPORTED TISSUE INJURY/DAMAGE CANNOT BE DETERMINED. TISSUE DAMAGE IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. SERIOUS INJURY/ILLNESS/IMPAIRMENT WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ AND PRE-EXISTING FLAIL. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE WITHOUT ISSUES. TO FURTHER REDUCE MR, A SECOND CLIP, A MITRACLIP XTW WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) INSERTED, POSITIONED LATERALLY TO THE FIRST CLIP, AND GRASPING AS PERFORMED. HOWEVER, DURING DEPLOYMENT OF THE SECOND CLIP, IT WAS NOT POSSIBLE TO RETRACT THE LOCK KNOB RELEASE SLIDER. IT WAS NOTED THAT THE SLIDER APPEARED TO BE BLOCKED. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE CONTINUED TO OCCUR. THEREFORE, THE CLIP WAS REMOVED FROM THE PATIENT. WHILE OUTSIDE THE PATIENT, IT WAS OBSERVED THAT A STRUCTURE WAS WRAPPED AROUND THE CLIP. IN THE PHYSICIAN¿S OPINION, THE STRUCTURE WAS CHORDAE. A THIRD CLIP WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299046 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0802-XTW 51016R1063 05415067050755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 1 IMPLANTED MITRACLIP.| STEERABLE GUIDE CATHETER.