BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 17356046 · Received July 19, 2023

    Report

    Report Number
    2135147-2023-03108
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 19, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037404
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON AVAILABLE INFORMATION, THE REPORTED TISSUE INJURY APPEARS TO BE DUE TO PROCEDURAL CONDITIONS. THE REPORTED MR IS A CASCADING EVENT OF THE TISSUE INJURY. ADDITIONALLY, TISSUE INJURY AND MR ARE LISTED IN THE IFU AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED SURGERY AND DELAY TO TREATMENT/THERAPY WERE THE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT TISSUE DAMAGE AND SURGICAL INTERVENTION. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT A DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4+ WITH POSTERIOR FLAIL AND PROLAPSED POSTERIOR LEAFLET. FIRST CLIP (XTW) WAS IMPLANTED ON THE FLAIL (P1/P2) WITH NO REPORTED ISSUE. THERE WAS AN ECCENTRIC MEDIAL JET JUST ADJACENT TO THE XTW. AN XT CLIP WAS STEERED DOWN THE VALVE. SEVERAL ATTEMPTS PERFORMED TO GRASP THE LEAFLETS AND REDUCE THE RESIDUAL MR. AFTER SEVERAL NON-IMPACTING GRASPS, A SUCCESSFUL GRASP WAS OBTAINED, AND MODERATE MR (2+ GRADE) WAS ACHIEVED. AFTER MUCH DISCUSSION AMONGST THE TEAM, IT WAS DETERMINED TO ATTEMPT TO MAXIMIZE GRASP BY RAISING POSTERIOR GRIPPER AND MAXIMIZE THE TISSUE CAPTURE ONCE AGAIN. AFTER AN UNSUCCESSFUL MAXIMIZATION ATTEMPT, THE CLIP WAS INVERTED AND PULLED BACK THRU TO THE ATRIUM. ANOTHER ATTEMPT WAS MADE WITH THE SAME XT CLIP. AFTER SEVERAL ATTEMPTS, A GRASP WAS ACHIEVED AND SEEN A 2+ GRADE REDUCTION AND STRONG HEMODYNAMIC RESPONSES IN THE PULMONARY VEINS FLOWS WHICH AT BASE LINE WERE SYSTOLIC REVERSED, WERE NOW SYSTOLIC DOMINATE FLOW. THERE WAS DISCUSSION THAT THE GOAL FOR THE TRIAL WAS TO ACHIEVE MILD MR GRADE. ANOTHER ATTEMPT TO REPOSITION THE CLIP WAS MADE TO FURTHER REDUCE MR GRADE. THE GRASP WAS GIVEN UP AND AT THAT TIME MORE MR FROM BASELINE WAS NOTED. TEE ASSESSMENT OF THE VALVE WAS THEN DONE, AND IT WAS DETERMINED THAT THERE WAS A TEAR IN THE POSTERIOR LEAFLET. IT WAS DECIDED TO REMOVE THE XT CLIP AND ABORT THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGICAL REPAIR OF THE MITRAL VALVE AND ANNULOPLASTY RING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910742 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0706-XT 20725R1016 05415067037404

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention 1 IMPLANTED MITRACLIP| STEERABLE GUIDE CATHETER