BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 9817787 · Received March 11, 2020

    Report

    Report Number
    2024168-2020-02250
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648226366
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 IDENTIFY A LOT SPECIFIC PRODUCT QUALITY ISSUE. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND A CAUSE FOR THE SINGLE LEAFLET DEVICE ATTACHMENT IN THIS INCIDENT COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE FIRST MITRACLIP NTR (GRIPPER ACTUATION) REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS IS FILED ON THE MITRACLIP XTR TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT GRADE 4 MIXED ETIOLOGY MITRAL REGURGITATION (MR). DURING FUNCTIONAL INSPECTION OF THE FIRST MITRACLIP NTR, IT WAS NOTED THAT ONLY ONE OF THE GRIPPERS WOULD LOWER OR RESPOND TO THE GRIPPER LEVER; THEREFORE, IT WAS NOT USED IN THE PATIENT. THE SECOND MITRACLIP WAS AN XTR AND WAS PREPARED WITHOUT ISSUE. THE XTR WAS THE FIRST MITRACLIP IMPLANTED IN THE PATIENT. THE SECOND MITRACLIP INSERTED IN THE PATIENT WAS AN NTR AND WAS PLACED MEDIAL TO THE FIRST CLIP; BUT THERE WAS NO CONTACT BETWEEN THE TWO CLIPS. WHEN THE NTR CLIP GRASPED THE LEAFLETS, THE POSTERIOR LEAFLET CAME OUT OF THE XTR CLIP RESULTING IN A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). THE NTR WAS IMPLANTED TO STABILIZE THE SLDA CLIP. THE PROCEDURE WAS COMPLETED WITH MR REMAINING AT GRADE 4. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279794 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR CDS0601-XTR 90222U193 08717648226366

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention OTHER MITRACLIP, CDS0601-NTR| STEERABLE GUIDE CATHETER