BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15142305 · Received August 1, 2022

    Report

    Report Number
    2135147-2022-00614
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 12, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648231001
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE CLIP WAS IMPLANTED AND THE CLIP DELIVERY SYSTEM (CDS) WAS REPORTEDLY DISCARDED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4). THE STEERABLE GUIDE CATHETER (SGC) MENTIONED IN B5 AND D10 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    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 THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THE REPORTED DEVICE DAMAGED BY ANOTHER DEVICE (CAUSED DAMAGE) AND MATERIAL PROTRUSION / EXTRUSION (ACTUATOR MANDREL (DISTAL)) APPEAR TO BE RELATED TO THE REPORTED USER ERROR (IMPROPER OR INCORRECT PROCEDURE OR METHOD) ASSOCIATED WITH FAILURE TO FOLLOW STEPS / INSTRUCTIONS AND INCORRECT REMOVAL PROCESS. THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD (FAILURE TO FOLLOW STEPS / INSTRUCTIONS) AND IMPROPER OR INCORRECT PROCEDURE OR METHOD (INCORRECT REMOVAL) WAS DUE TO THE USER DID NOT RETRACT THE MANDREL PROPERLY IN THE CLIP INTRODUCER BEFORE REMOVING THE CDS AND SGC TOGETHER. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THIS IS BEING FILED FOR A DEVICE THAT CAUSED DAMAGE TO ANOTHER DEVICE. IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH GRADE 4 PRIMARY MITRAL REGURGITATION (MR). AN XTW CLIP WAS SUCCESSFULLY IMPLANTED. THE STEERABLE GUIDE CATHETER (SGC) WAS IN THE PATIENT WHEN A LOSS OF COLUMN AND BLOOD WAS OBSERVED. ADDITIONAL ASPIRATION WAS NEEDED OUTSIDE OF STANDARD INSTRUCTION FOR USE (IFU) PROCEDURE. THE COLUMN WAS STILL NOT HOLDING, AND IT WAS DISCOVERED THAT THE STOPCOCK WAS CRACKED ON THE SGC. THE PHYSICIAN QUICKLY REMOVED THE SGC ALONG WITH THE CLIP DELIVERY SYSTEM (CDS), AS THE XTW WAS ALREADY DEPLOYED. THE CDS WAS REMOVED WITHOUT FULLY RETRACTING THE SPEAR (DISTAL MANDREL) INTO THE INTRODUCER, AND POTENTIALLY LACERATED THE HEMOSTASIS VALVE OF THE SGC. THE CDS WAS REMOVED AND A NEW SGC WAS PREPPED. THE PROCEDURE WAS COMPLETED WITH A 2ND CLIP IMPLANTED, REDUCING THE MR TO 1-2. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828444 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0701-XTW 20124R277 08717648231001

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male STEERABLE GUIDE CATHETER