BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 12953977 · Received December 7, 2021

    Report

    Report Number
    2024168-2021-11195
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 12, 2021
    Report Date
    December 7, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648231001
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE REPORTED DIFFICULTY GRASPING, DIFFICULT GRIPPER ACTUATION AND POOR IMAGE RESOLUTION APPEAR TO BE TO HAVE BEEN RESULTS OF CHALLENGING PATIENT ANATOMY. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL MITRACLIP DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT GRIPPER ACTUATION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. IT WAS NOTED FLAIL LEAFLETS AND VISUALIZATION WAS DIFFICULT TO DUE TO SHADOWING ESOPHAGUS. THE FIRST CLIP DELIVERY SYSTEM (CDS 10616R380 ) WAS ADVANCED TO THE MITRAL VALVE, AND THE CLIP WAS DEPLOYED. HOWEVER, THE CLIP BECAME DETACHED FROM THE POSTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THEREFORE, A SECOND CDS (10526R104) WAS ADVANCED TO THE MITRAL VALVE; HOWEVER, THE CLIP COULD NOT GRASP BOTH LEAFLETS LATERAL TO THE SLDA DUE TO SIGNIFICANT MOTION OF THE LEAFLET AND THE CLIP ROTATED TO THE LATERAL SIDE SO IT WAS INTERFERING WITH THE ABILITY TO LOWER THE GRIPPERS. THEREFORE, THE CLIP WAS PLACED MEDIAL. THE CLIP WAS DEPLOYED TO STABILIZE THE SLDA. THE PHYSICIAN STATED THE CAUSE OF THE SLDA WAS DUE TO INTEGRITY OF FLAIL LEAFLETS. TWO CLIPS WERE IMPLANTED, REDUCING MR TO 1+. THERE WERE 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
    1847778 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-XTW 10526R104 08717648231001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male 1 IMPLANTED MITRACLIP| STEERABLE GUIDE CATHETER