BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 20644077 · Received November 8, 2024

    Report

    Report Number
    2135147-2024-05631
    Event Type
    Death
    Date Received
    November 8, 2024
    Date of Event
    December 31, 2021
    Report Date
    December 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) REVIEW WAS NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION FROM THE ARTICLE, THE REPORTED OFF-LABEL USE WAS ASSOCIATED WITH THE USE OF A MITRACLIP DEVICE ON THE TRICUSPID VALVE. THE CAUSE OF THE REPORTED DEATH, HEART FAILURE, MYOCARDIAL INFARCTION, AND ARRHYTHMIA WERE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECTS OF ARRHYTHMIA, DEATH, MYOCARDIAL INFARCTION, AND HEART FAILURE, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND SURGICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. B2: DATE OF DEATH WAS ESTIMATED AS ON (B)(6) 2021 TO END OF STUDY RANGE. B3: DATE OF EVENT WAS ESTIMATED AS 1/1/2019 THE BEGINNING OF THE STUDY RANGE. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A: THE DATE OF IMPLANT WAS ESTIMATED TO ON (B)(6) 2019.

    Description of Event or Problem · 0

    THE ARTICLE, ¿REAL-WORLD PATIENT ELIGIBILITY AND FEASIBILITY OF TRANSCATHETER EDGE-TO-EDGE REPAIR OR REPLACEMENT INTERVENTIONS FOR TRICUSPID REGURGITATION¿, WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO ASSESS THE FEASIBILITY OF EMERGING TRANSCATHETER TRICUSPID THERAPIES IN A REAL-WORLD POPULATION WITH GREATER THAN OR EQUAL TO MODERATE SYMPTOMATIC TR (TRICUSPID REGURGITATION). DEVICES THAT WERE ASSOCIATED WITH THE STUDY WERE ABBOTT TRICLIP AND MITRACLIP SYSTEMS AND THE NON-ABBOTT PASCAL AND EVOQUE TRICUSPID VALVE REPLACEMENT DEVICE. ALL TRICLIP PROCEDURES ARE MONITORED AND REPORTED VIA THE TRIAL, TRILUMINATE POST-APPROVAL STUDY (PAS). THE ARTICLE CONCLUDED THAT THE PRESENT REAL WORLD ANALYSIS HIGHLIGHTS THAT ONLY A MINORITY OF TR PATIENTS APPEAR ELIGIBLE FOR NOVEL TRANSCATHETER INTERVENTIONS FOR TRICUSPID REPAIR/REPLACEMENT. THE PRIMARY AUTHOR OF THE ARTICLE IS ABDEL RAHMAN ABUSHOUK, MD DEPARTMENT OF CARDIOVASCULAR MEDICINE, HEART, VASCULAR, AND THORACIC INSTITUTE, CLEVELAND CLINIC FOUNDATION, CLEVELAND, OHIO. THE CORRESPONDENCE AUTHOR IS RISHI PURI, MD, PHD, DEPARTMENT OF CARDIOVASCULAR MEDICINE HEART, VASCULAR & THORACIC INSTITUTE, CLEVELAND CLINIC, MAIL CODE J2-208, 9500 EUCLID AVENUE, CLEVELAND, OH 44195. E-MAIL: [email protected] THE TIME RANGE OF THE STUDY WAS BETWEEN JANUARY 2019 AND DECEMBER 2021. THE STUDY INCLUDED 178 PATIENTS WITH A MEAN AVERAGE AGE OF 77 AND MAJORITY WERE FEMALE. COMORBIDITIES INCLUDE: HYPERTENSION, DIABETES MELLITUS, PRIOR MYOCARDIAL INFARCTION, DYSLIPIDEMIA, PREVIOUS STROKE, HEART FAILURE HOSPITALIZATION, ATRIAL FIBRILLATION, PRIOR PACEMAKER INSERTION, GASTROINTESTINAL BLEEDING, CORONARY ARTERY DISEASE, TRICUSPID REGURGITATION (PRIMARY, SECONDARY AND MIXED), MITRAL REGURGITATION (PRIMARY, SECONDARY AND MIXED), RIGHT ATRIAL PRESSURE, RIGHT ATRIAL DILATATION, PULMONARY HYPERTENSION, DECREASE RIGHT VENTRICLE FUNCTION. ADVERSE EVENTS INCLUDED: DEATH, HEART FAILURE HOSPITALIZATIONS, MYOCARDIAL INFARCTION, TRICUSPID REGURGITATION, AND PERMANENT PACEMAKER (ARRHYTHMIA AND SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110795 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| D| H