BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 21386526 · Received February 14, 2025

    Report

    Report Number
    2135147-2025-00754
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    March 1, 2023
    Report Date
    April 4, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED "FEASIBILITY OF A SYSTEMATIC SAME-DAY DISCHARGE APPROACH AFTER ELECTIVE MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR. "

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH UNKNOWN CO-MORBIDITIES. COMPLICATIONS REPORTED INCLUDED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), HEART FAILURE, PROLONGED HOSPITALIZATION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE "FEASIBILITY OF A SYSTEMATIC SAME-DAY DISCHARGE APPROACH AFTER ELECTIVE MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR" WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE SINGLE CENTER) STUDY, TO EVALUATE THE FEASIBILITY OF A SYSTEMATIC SAME-DAY DISCHARGE (SDD) APPROACH FOR PATIENTS WHO ARE CANDIDATES FOR ELECTIVE M-TEER OVER 1 YEAR. DEVICES MENTIONED INCLUDE MITRACLIP. THE ARTICLE CONCLUDED THAT COMPARED TO STANDARD APPROACH, SDD REDUCES BED OCCUPANCY, HOSPITALIZATION COSTS, AND THE IMPACT ON PATIENT OUTCOMES. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS GUILLAUME LEURENT AT CHU DE RENNES INSTITUTION WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS MARCH 2023 TO MARCH 2024. A TOTAL OF 15 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 15 RECEIVED AN ABBOTT DEVICE. AS THIS EVENT IS FROM A LITERATURE REVIEW, THERE IS NO RELEVANT PATIENT INFORMATION (DATE OF BIRTH, AGE, GENDER, WEIGHT, AND MEDICAL HISTORY) TO REPORT. COMORBIDITIES WERE NOT GIVEN. (B)(6), UNK MITRACLIP PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), HEART FAILURE, PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150881 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown