BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 22347524 · Received June 27, 2025

    Report

    Report Number
    2135147-2025-03509
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION DETERMINED THE REPORTED SLDA APPEARS TO BE RELATED TO PATIENT CONDITIONS. THE REPORTED PATIENT EFFECT OF RECURRENT MR AND SUBSEQUENT HEART FAILURE AND RENAL FAILURE APPEARS TO BE RELATED TO THE SLDA. MR, HEART FAILURE, AND RENAL FAILURE 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 WAS HOSPITALIZED AND UNDERWENT MITRAL VALVE REPLACEMENT. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR) AND BARLOW'S DISEASE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS (NTW AND XTW) WERE IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE MR WAS REDUCED TO GRADE 2. ON (B)(6) 2025, APPROXIMATELY 48 HOURS POST PROCEDURE, A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED AND THE SECOND MITRACLIP NTW HAD A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). PER THE PHYSICIAN, THE ANTERIOR LEAFLET BECAME DETACHED DUE TO A SICK VALVE FROM BARLOW'S DISEASE. THE MR GRADE WAS INCREASED TO GRADE 4+ POST-SLDA AND THE PATIENT WAS HOSPITALIZED FOR PULMONARY EDEMA. ON (B)(6) 2025, A REDO PROCEDURE WAS PERFORMED. A MITRACLIP NT WAS IMPLANTED LATERAL TO THE NTW CLIP AND AN XT CLIP WAS POSITIONED BETWEEN THE NTW AND XTW. THE MR WAS REDUCED TO GRADE 1-2+ POST PROCEDURE. ON APPROXIMATELY 20 DAYS ((B)(6) 2025) AFTER THE SECOND PROCEDURE, PATIENT BEGAN SHOWING SIGNS OF CONGESTION DUE TO THE SLDA OF CLIPS. THE PATIENT HAD SIGNIFICANT DECOMPENSATION AND WAS PUT ON DIALYSIS. DURING HOSPITALIZATION, THE PATIENT UNDERWENT VALVE REPLACEMENT SURGERY AND IS CURRENTLY IN INTENSIVE CARE UNIT(ICU). NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR) AND BARLOW'S DISEASE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS (NTW AND XTW) WERE IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE MR WAS REDUCED TO GRADE 2. ON (B)(6) 2025, APPROXIMATELY 48 HOURS POST PROCEDURE, A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED AND THE SECOND MITRACLIP NTW HAD A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). PER THE PHYSICIAN, THE ANTERIOR LEAFLET BECAME DETACHED DUE TO A SICK VALVE FROM BARLOW'S DISEASE. THE MR GRADE WAS INCREASED TO GRADE 4+ POST-SLDA AND THE PATIENT WAS HOSPITALIZED FOR PULMONARY EDEMA. ON (B)(6) 2025, A REDO PROCEDURE WAS PERFORMED. A MITRACLIP NT WAS IMPLANTED LATERAL TO THE NTW CLIP AND AN XT CLIP WAS POSITIONED BETWEEN THE NTW AND XTW. THE MR WAS REDUCED TO GRADE 1-2+ POST PROCEDURE. AT APPROXIMATELY 20 DAYS ((B)(6) 2025) AFTER THE SECOND PROCEDURE, PATIENT BEGAN SHOWING SIGNS OF CONGESTION DUE TO THE SLDA OF CLIPS. THE PATIENT HAD SIGNIFICANT DECOMPENSATION AND WAS PUT ON DIALYSIS. DURING HOSPITALIZATION, THE PATIENT UNDERWENT VALVE REPLACEMENT SURGERY AND IS CURRENTLY IN INTENSIVE CARE UNIT(ICU). NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973188 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| O| H 3 MITRACLIPS| STEERABLE GUIDE CATHETER