BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 21609527 · Received March 14, 2025

    Report

    Report Number
    2135147-2025-01314
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037435
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 MITRAL STENOSIS, TACHYCARDIA, AND RECURRENT MR. MITRAL STENOSIS, TACHYCARDIA, AND MR ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND SURGICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES AS THE PATIENT RETURNED TO THE HOSPITAL AND UNDERWENT SURGICAL INTERVENTION. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4 WITH A MITRAL VALVE GRADIENT (MVG) OF 4-5MMHG. ONE CLIP WAS IMPLANTED REDUCING MR TO GRADE 1-2, AND MVG ENDED AT 8MMHG. THE FOLLOWING DAY, IMAGING SHOWED MODERATE MITRAL STENOSIS AND MILD MR. THE SAME WAS NOTED BY IMAGING ON (B)(6) 2025. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, HOWEVER RETURNED TO THE HOSPITAL WITH TACHYCARDIA. IMAGING WAS PERFORMED AGAIN ON (B)(6) 2025, BOTH INDICATING SEVERE MITRAL STENOSIS AND MILD MR. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 TO REPAIR THE MITRAL VALVE.

    Description of Event or Problem · 0

    IT WAS REPORTED A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4 WITH A MITRAL VALVE GRADIENT (MVG) OF 4-5MMHG. ONE CLIP WAS IMPLANTED REDUCING MR TO GRADE 1-2, AND MVG ENDED AT 8MMHG. THE FOLLOWING DAY, IMAGING SHOWED MODERATE MITRAL STENOSIS AND MILD MR. THE SAME WAS NOTED BY IMAGING ON (B)(6) 2025. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, HOWEVER RETURNED TO THE HOSPITAL WITH TACHYCARDIA. IMAGING WAS PERFORMED AGAIN ON (B)(6) 2025 AND (B)(6) 2025, BOTH INDICATING SEVERE MITRAL STENOSIS AND MILD MR. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 TO REPAIR THE MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112305 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40205A2096 05415067037435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H