BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 21492797 · Received February 28, 2025

    Report

    Report Number
    2135147-2025-01025
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    November 1, 2012
    Report Date
    March 19, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES, PRIOR HEART SURGERY, ATRIAL FIBRILLATION. COMPLICATIONS REPORTED INCLUDED STROKE, BLEEDING, DEATH; 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. LITERATURE ATTACHMENT: ARTICLE TITLE "DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS AFTER MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR IN PATIENTS WITH ATRIAL FIBRILLATION_ A SINGLE-CENTER OBSERVATIONAL STUDY".

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE ARTICLE "DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS AFTER MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR IN PATIENTS WITH ATRIAL FIBRILLATION: A SINGLE-CENTER OBSERVATIONAL STUDY" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY, TO EVALUATE DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS AFTER MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR IN PATIENTS WITH ATRIAL FIBRILLATION. DEVICES MENTIONED INCLUDE MITRACLIP AND A NON-ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT DIRECT ORAL ANTICOAGULANTS MAY OFFER COMPARABLE EFFICACY AND SAFETY TO VKAS IN PREVENTING THROMBOEMBOLIC EVENTS FOLLOWING M-TEER IN PATIENTS WITH ATRIAL FIBRILLATION. FURTHER RANDOMIZED TRIALS ARE NEEDED TO CONFIRM THESE RESULTS AND ESTABLISH OPTIMAL ANTICOAGULATION STRATEGIES IN THIS PATIENT POPULATION. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS JAN-HENDRIK SCHIPPER AT UNIVERSITY HOSPITAL COLOGNE INSTITUTION WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS NOVEMBER 2012 TO APRIL 2019. A TOTAL OF 206 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH AN UNKNOWN AMOUNT OF PATIENTS 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 INCLUDED HYPERTENSION, DIABETES, PRIOR HEART SURGERY, ATRIAL FIBRILLATION. (B)(6), UNK MITRACLIP: PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDE STROKE, BLEEDING, DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665680 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other