BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 19260514 · Received May 7, 2024

    Report

    Report Number
    2135147-2024-02035
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 12, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648288647
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED PARTIAL CLIP MOVEMENT AND TISSUE INJURY WERE UNABLE TO BE DETERMINED. THE REPORTED RECURRENT MR WAS A CASCADING EVENT OF THE REPORTED PARTIAL CLIP MOVEMENT AND TISSUE INJURY. THE REPORTED DYSPNEA AND HEART FAILURE WERE LIKELY CASCADING EVENTS OF THE REPORTED RECURRENT MR. THE REPORTED PATIENT EFFECTS OF DYSPNEA, HEART FAILURE, MITRAL REGURGITATION, AND TISSUE INJURY, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND MEDICATION REQUIRED WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B5-- DESCRIBE EVENT OR PROBLEM: PROCEDURE DESCRIPTION UPDATED. H6- ADVERSE EVENT PROBLEM HEALTH EFFECT - CLINICAL CODE: 1816 DYSPNEA ADDED. H6- ADVERSE EVENT HEALTH EFFECT - IMPACT CODE: 4644 MEDICATION REQUIRED ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE UNKNOWN. AT AN UNKNOWN POINT POST PROCEDURE, PERFORATION OF THE ANTERIOR LEAFLET WAS SUSPECTED. MR GRADE WAS MODERATE TO SEVERE. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO CONGESTIVE HEART FAILURE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 3-4, REDUCING MR TO TRACE. ON (B)(6) 2024, THE PATIENT RETURNED WITH RESPIRATORY DISTRESS. ULTRASOUND WAS PERFORMED, CONFIRMING A PERFORATION OF THE ANTERIOR LEAFLET. MR GRADE WAS RECURRENT MODERATE TO SEVERE. THE CLIP WAS STABLE ON THE LEAFLETS BUT, CLIPS ARM ON THE ANTERIOR LEAFLET WAS PROTRUDING TOWARDS THE LEFT ATRIUM WITH AN MR JET GOING THROUGH THE PERFORATION. MEDICATION WAS PROVIDED, NO SURGICAL INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454281 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 30925R2102 08717648288647

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization| O| R