BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP

    MDR report key: 21774632 · Received April 4, 2025

    Report

    Report Number
    2135147-2025-01750
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037428
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED BRADYCARDIA, AIR EMBOLISM, AND MYOCARDIAL INFARCTION. BRADYCARDIA, AIR EMBOLISM, AND MYOCARDIAL INFARCTION ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCE AS THE PATIENT WAS RESUSCITATED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), DILATED LEFT ATRIUM AND A PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. TWO MITRACLIP NTWS AND ONE MITRACLIP NT WERE IMPLANTED. THE MR WAS REDUCED TO GRADE 1. ON AN ESTIMATED DATE, (B)(6) 2025, 31 TO 90 DAYS POST PROCEDURE THE PATIENT RETURNED AND AN ECHOCARDIOGRAM SHOWED MR WAS RECURRENT AT GRADE 4 AND THE CLIPS WERE STABLE ON BOTH LEAFLETS. ON (B)(6) 2025, THE PATIENT PRESENTED WITH GRADE 4 MR FOR A MITRACLIP PROCEDURE. THERE WAS DIFFICULTY GRASPING AND CAPTURING THE LEAFLETS DUE TO THE PREVIOUSLY IMPLANTED CLIPS. IT WAS REPORTED THAT THERE WAS DIFFICULTY VISUALIZING THE CLIP DUE TO SHADOWING OF THE DEVICES. AFTER MULTIPLE ATTEMPTS, THE CLIP WAS REMOVED. THE PROCEDURE WAS DISCONTINUED WITHOUT IMPLANTING ANY CLIPS. THE FINAL MR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744313 MITRACLIP MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0707-NTW 41001A1083 05415067037428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H| R 2 IMPLANTED MITRACLIPS| MITRACLIP X2