BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15612671 · Received October 15, 2022

    Report

    Report Number
    2135147-2022-01641
    Event Type
    Injury
    Date Received
    October 15, 2022
    Date of Event
    September 13, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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.

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THIS PATIENT WAS DISCOVERED A DUPLICATE OF (B)(4), PREVIOUSLY REPORTED MEDWATCH REPORT NUMBER 2135147-2022-01515-00. (B)(4) WILL CAPTURE THE REPORTED EVENT AND INVESTIGATION. THE DEVICE ANALYSIS AND INVESTIGATION IS NOT YET COMPLETE FOR (B)(4). A FOLLOW-UP REPORT WILL BE GENERATED WITH (B)(4), REPORTING THE ADDITIONAL INFORMATION.B1 AND B2: UPDATED TO THE DUPLICATE OUTCOME. THE SAME PATIENT AND SINGLE LEAFLET DEVICE ATTACHMENT EVENT HAS BEEN PREVIOUSLY REPORTED IN (B)(4) MEDWATCH REPORT 2135147-2022-01515-00. B3: UPDATED. D9, H3: DEVICE RETURN UPDATED TO YES. THE DEVICE RETURN AND INVESTIGATION ARE BEING CAPTURED IN (B)(4). E1: ADDRESS UPDATED. G2: REPORT SOURCE UPDATED. H6: HEALTH EFFECT CLINICAL CODE 4451 REMOVED AND REPLACED WITH 4582 HEALTH EFFECT IMPACT CODE 4614 REMOVED AND REPLACED WITH 2199 MEDICAL DEVICE PROBLEM CODE 2507 REMOVED AND REPLACED WITH 3189. PLEASE NOTE: THE HEALTH AND DEVICE CODES ARE CAPTURED IN THE DUPLICATE EVENT (B)(4). A FINAL REPORT WILL BE SUBMITTED, INCLUDING THE DEVICE ANALYSIS AND COMPLETED INVESTIGATION, WITH (B(4).

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT AND WORSENING MITRAL REGURGITATION. IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT A MITRACLIP PROCEDURE WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR). AN XTW CLIP (20120R114) WAS SUCCESSFULLY IMPLANTED REDUCING THE MR TO A GRADE OF 2. ON (B)(6) 2022, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OF THE ANTERIOR LEAFLET WAS FOUND DURING A FOLLOW-UP VISIT. THE MR INCREASED TO A GRADE OF 4+. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT: THIS PATIENT WAS DISCOVERED A DUPLICATE OF (B)(4), PREVIOUSLY REPORTED MEDWATCH REPORT NUMBER 2135147-2022-01515-00. (B)(4) WILL CAPTURE THE REPORTED EVENT AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886608 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL N/A 20120R114

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| S| O| R 1 IMPLANTED MITRACLIP