BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 11208520 · Received January 21, 2021

    Report

    Report Number
    2024168-2021-00580
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 29, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648230967
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE ANALYSIS CONFIRMED THE REPORTED ISSUE OF THE MATERIAL SEPARATION AS THE CLIP INTRODUCER (CI) TUBING MATERIAL WAS OBSERVED TO BE DETACHED FROM THE CLIP INTRODUCER HOUSING AND NOT BONDED TOGETHER. THE REPORTED LEAK/SPLASH AND LOOSE OR INTERMITTENT CONNECTION OF THE CI WITH THE STEERABLE GUIDE CATHETER (SGC) COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE RETURNED CONDITION OF THE DEVICE (CI MATERIAL SEPARATION). ADDITIONALLY, IT WAS NOTED THAT THE NON-TACTILE MARKER GRIPPER LEVER CAP AND THE LATCH WERE DETACHED FROM THE DEVICE. THE INVESTIGATION IDENTIFIED THE LOSS OF OR FAILURE TO BOND BETWEEN THE CI HOUSING AND THE TUBING AND THE CI MATERIAL SEPARATION RESULTING IN THE REPORTED LEAK AND LOOSE OR INTERMITTENT CONNECTION AS POTENTIAL PRODUCT ISSUE. ADDITIONALLY, THE INVESTIGATION DETERMINED THE OBSERVED GRIPER LEVER CAP AND LATCH SEPARATION AS A POTENTIAL PRODUCT ISSUE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS FROM THE LOT. BASED ON THE INFORMATION REVIEWED AND THE ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION IDENTIFIED THE LOSS OF OR FAILURE TO BOND BETWEEN THE CI HOUSING AND THE TUBING AND THE CI MATERIAL SEPARATION RESULTING IN THE REPORTED LEAK AND LOOSE OR INTERMITTENT CONNECTION AND THE OBSERVED NON-TACTILE MARKER GRIPPER LEVER CAP AND THE LATCH SEPARATION AS POTENTIAL QUALITY ISSUES. THE ISSUES ARE BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT A LEAK, LOOSE CONNECTION AND MATERIAL SEPARATION IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4. ONE NTW CLIP WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUES. A SECOND NTW CLIP (00928U327) WAS INSERTED INTO THE STEERABLE GUIDE CATHETER (SGC). HOWEVER, THE PHYSICIAN NOTICED THAT THE HUB OF THE CLIP INTRODUCER (CI) DID NOT COME TOGETHER WITH THE BACK END OF THE SGC AS SECURELY AS USUAL. THIS CAUSED AIR TO ENTER THE SGC. THE SYSTEM WAS LOWERED BELOW THE PATIENT HEART AND ASPIRATION WAS PERFORMED, BUT THE BUBBLE IN THE SGC DID NOT MOVE. SINCE THE BUBBLE WAS IMMOBILE, THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE. THE CLIP WAS SUCCESSFULLY DEPLOYED, REDUCING MR TO A GRADE OF 1. HOWEVER, AFTER THE CLIP DELIVERY SYSTEM (CDS) WAS REMOVED FROM THE SGC, IT WAS NOTICED THAT THE SOFT PORTION OF THE CI HAD COMPLETELY DETACHED FROM THE PLASTIC PORT. NO ADDITIONAL CLIPS WERE IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103454 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-NTW 00928U327 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention IMPLANTED MITRACLIP| STEERABLE GUIDE CATHETER| IMPLANTED MITRACLIP| STEERABLE GUIDE CATHETER