BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15997252 · Received December 16, 2022

    Report

    Report Number
    2135147-2022-02622
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    October 1, 2022
    Report Date
    February 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL MITRACLIP REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC PRODUCT ISSUE. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED INCOMPLETE COAPTATION/SLDA APPEARS TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY AND DUE TO A GAP. MITRAL VALVE INSUFFICIENCY/ REGURGITATION AND HEART FAILURE APPEAR TO BE DUE TO THE SLDA. MITRAL REGURGITATION AND HEART FAILURE ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.4003 WAS REMOVED.

    Description of Event or Problem · 0

    THIS IS BEING FILED TO REPORT A MITRACLIP NTW THAT HAD A POST-PROCEDURAL SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH GRADE 3 FUNCTIONAL MITRAL REGURGITATION (MR). A MITRACLIP NTW WAS IMPLANTED, REDUCING THE MR TO GRADE <1. APPROXIMATELY ON (B)(6) 2022, THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND A DETACHMENT FROM THE POSTERIOR LEAFLET. A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAD OCCURRED. ON (B)(6) 2022, SECOND CLIP INTERVENTION WAS PERFORMED. IT WAS NOTED THAT THERE WAS MINOR ECHOCARDIOGRAPHY IMAGING DIFFICULTY. THE MR WAS GRADE 4 AND TWO MITRACLIP NTS WERE INTENDED TO BE IMPLANTED TO STABILIZE THE NTW AND FURTHER REDUCE THE MR. THE FIRST NT WAS IMPLANTED MEDIAL TO THE NTW, AND THE NT DETACHED FROM THE ANTERIOR LEAFLET ONCE IT WAS DEPLOYED. AN SLDA WAS OBSERVED. THE NTW PARTIALLY DETACHED FROM THE ANTERIOR LEAFLET. THE SECOND NT WAS IMPLANTED LATERAL TO THE NTW CLIP, REDUCING THE MR TO GRADE 1+. THERE WERE NO ADVERSE PATIENT SEQUELAE OR TISSUE DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152161 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 11108R142

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention