BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 15580189 · Received October 11, 2022

    Report

    Report Number
    2135147-2022-01575
    Event Type
    Death
    Date Received
    October 11, 2022
    Date of Event
    September 1, 2010
    Report Date
    December 7, 2022
    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

    AGE: AVERAGE AGE. SEX: MAJORITY GENDER. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND DEVICE MALFUNCTION, REFERENCED, ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE: ¿TRANSCATHETER EDGE-TO-EDGE REPAIR FOR ATRIAL SECONDARY MITRAL REGURGITATION.¿

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE PREVIOUS REPORT, THIS EVENT WAS DISCOVERED A DUPLICATE OF A PREVIOUSLY FILED E-117809 // (B)(6). THE EVENT CAPTURE AND INVESTIGATION WILL REMAIN CAPTURED IN E-117809 // (B)(6). PLEASE REFERENCE (B)(6) MEDWATCH REPORT NUMBERS FOR THE REPORTED EVENT AND INVESTIGATION. 2135147-2022-01309-01. 2135147-2022-01310-01. 2135147-2022-01311-01. 2135147-2022-01309-00. 2135147-2022-01310-00. 2135147-2022-01311-00. NO FURTHER INVESTIGATION IS REQUIRED. H6: HEALTH EFFECT CLINICAL CODES 4582 ADDED. HEALTH EFFECT IMPACT CODE 1802 REMOVED AND REPLACED WITH 2199. MEDICAL DEVICE PROBLEM CODE 2993 REMOVED AND REPLACED WITH 3189.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE MITRACLIP DEVICE MAY BE RELATED TO RECURRENT MITRAL REGURGITATION (MR), DEATH, MITRAL STENOSIS, INSUFFICIENT MR REDUCTION, BLEEDING, SEPSIS, AND SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) REQUIRING REINTERVENTION. THE STUDY FOUND THAT USE OF THE NEWER GENERATIONS OF MITRACLIPS (NTR/XTR OR G4) WERE ASSOCIATED WITH THE OPTIMAL MR REDUCTION IN PATIENTS WITH ATRIAL SECONDARY MITRAL REGURGITATION (ASMR), AND THE NUMBER OF IMPLANTED CLIPS WAS LIKELY TO BE LESS IN THE NEWER GENERATIONS. IN CONCLUSION, TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) ACHIEVED A HIGH RATE OF MR REDUCTION IN PATIENTS WITH ASMR. SEVERE LEFT ATRIAL DILATION AND A LOW LEAFLET TO ANNULAR INDEX (LAI) WERE ASSOCIATED WITH A LOW INCIDENCE OF THE MR REDUCTION AFTER TEER. OUR FINDINGS HIGHLIGHT THAT TEER IS A SAFE AND FEASIBLE OPTION FOR PATIENTS WITH ASMR AND MAY REFINE DEVICE SELECTION FOR TRANSCATHETER MITRAL VALVE TREATMENTS IN THIS SUBGROUP OF SMR PATIENTS. DETAILS PROVIDED IN THE ARTICLE TITLED: "TRANSCATHETER EDGE-TO-EDGE REPAIR FOR ATRIAL SECONDARY MITRAL REGURGITATION."

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: THIS WAS DISCOVERED A DUPLICATE OF E-117809 // (B)(6). THE INITIAL MDR'S WERE ALREADY FILED AND THEREFORE, A FOLLOW-UP REPORT IS BEING SENT, REPORTING THAT A DUPLICATE CN, (B)(6), HAS ALREADY BEEN FILED AND WILL CAPTURE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359749 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death