BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 24877746 · Received April 14, 2026

    Report

    Report Number
    2135147-2026-02443
    Event Type
    Death
    Date Received
    April 14, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE LOT HISTORY RECORD (LHR) AND COMPLAINT HISTORY REVIEW WAS NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, THE CAUSE OF THE DIFFICULT LEAFLET CAPTURE, TISSUE INJURY, AND DEATH WERE UNABLE TO BE DETERMINED. THE REPORTED EMBOLISM APPEARS TO BE RELATED TO THE REPORTED TISSUE INJURY. THE REPORTED EKG/ECG CHANGES WERE LIKELY RELATED TO THE REPORTED EMBOLISM. THE REPORTED PATIENT EFFECTS OF DEATH, TISSUE INJURY, EMBOLISM, AND EKG/ECG CHANGES AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL WAS THE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE, "MITRAL LEAFLET FRAGMENT EMBOLIZATION CAUSING CORONARY OCCLUSION DURING RESCUE TRANSCATHETER MITRAL VALVE REPAIR FOR ACUTE MITRAL REGURGITATION", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 77-YEAR-OLD FEMALE PATIENT WITH DYSPNEA, RESPIRATORY DISTRESS, CYANOSIS, ORTHOPNEA, HYPOXEMIA, HOLOSYSTOLIC APICAL MURMUR AND DIFFUSE PULMONARY RALES, POSTERIOR LEAFLET FLAIL, AND SEVERE MITRAL REGURGITATION. ON AN UNKNOWN DATE, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR). AN XTW CLIP WAS INSERTED AND GRASPING WAS PERFORMED. WHILE CLOSING THE ARM, THE POSTERIOR LEAFLET DISAPPEARED FROM BETWEEN THE CLIP ARMS AND GRIPPERS. THE CLIP WAS THEN REPOSITIONED AND GRASPING WAS PERFORMED AGAIN. HOWEVER, ST ELEVATION WAS OBSERVED. EMERGENT CORONARY ANGIOGRAPHY SHOWED ACUTE COMPLETE OCCLUSION OF THE RIGHT CORONARY ARTERY. A BALLOON ANGIOPLASTY RESTORED ANTEGRADE FLOW. DUE TO THE CLIPPING OF THE A3-P3 SEGMENT, GRASPING REMAINED UNACHIEVABLE AND SEVERE MR REMAINED. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE, AND THE PATIENT DIED ON HOSPITAL DAY 4. AUTOPSY SHOWED MULTIPLE EVENLY SPACED PERFORATIONS CONSISTENT WITH PENETRATION BY THE GRIPPERS. HISTOPATHOLOGY OF THE RCA OBSTRUCTION REVEALED AN EMBOLUS COMPOSED OF TISSUE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS YASUHIDE MOCHIZUKI, DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, SHOWA MEDICAL UNIVERSITY SCHOOL OF MEDICINE, TOKYO, JAPAN, WITH CORRESPONDING EMAIL: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541799 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1