BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 19214010 · Received April 30, 2024

    Report

    Report Number
    2135147-2024-01910
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 8, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE RETURNED DEVICE ANALYSIS DID NOT CONFIRM THE REPORTED UNSTABLE ARM POSITIONER AND MISALIGNED GRIPPER (PRODUCT QUALITY PROBLEM). THE REPORTED INABILITY TO CLOSE THE CLIP, HOWEVER, WAS CONFIRMED. THE REPORTED DIFFICULT OR DELAYED POSITIONING ¿ ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. ADDITIONALLY, IT WAS NOTED THAT THE COLLET WAS BROKEN. THE INVESTIGATION DETERMINED THE OBSERVED BROKEN COLLET RESULTING IN THE INABILITY TO FULLY CLOSE THE CLIP TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE, THEREFORE, EXCEPTION (ISSUE) 131861 WAS INITIATED FOR FURTHER INVESTIGATION. 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 INDICATE A LOT-SPECIFIC PRODUCT ISSUE. ALL INFORMATION WAS INVESTIGATED AND BASED ON THE INFORMATION PROVIDED AND THE ANALYSIS OF THE RETURNED DEVICE, THE REPORTED DIFFICULT OR DELAYED POSITIONING WITH THE ANATOMY ASSOCIATED WITH THE CLIP BECOMING CAUGHT ON THE CHIARI NETWORK RESULTING IN PRODUCT QUALITY PROBLEM ASSOCIATED WITH MISALIGNED GRIPPER APPEARS TO BE RELATED PATIENT CONDITIONS AND DUE TO A PROMINENT CHIARI NETWORK. A CAUSE FOR UNSTABLE ARM POSITIONER, HOWEVER, COULD NOT BE DETERMINED. THE INVESTIGATION DETERMINED THAT THE OBSERVED BROKEN COLLET RESULTING IN THE INABILITY TO FULLY CLOSE THE CLIP APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP CONFIRMED THE ISSUE NOT TO BE RELATED TO THE MANUFACTURE, DESIGN OR LABELING OF THE PRODUCT; HOWEVER, A POTENTIAL ROOT CAUSE RELATED TO METHOD WAS DETERMINED BUT WAS NOT RETAINED AS A KNOWN ROOT CAUSE AS THERE WAS NO VERIFIED EVIDENCE OF DAMAGE OCCURRING DURING MANUFACTURING. ADDITIONALLY, IT WAS CONFIRMED THAT THE CALCULATED OCCURRENCE RISK LEVEL IS WITHIN THE EXPECTED RATE PER THE RISK ASSESSMENT. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A TRICLIP PROCEDURE TO TREAT TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5+ AND A PROMINENT CHIARI NETWORK. AN XTW WAS INSERTED BUT BECAME CAUGHT IN THE CHIARI NETWORK. THE CLIP WAS ABLE TO BE FREED FROM THE CHIARI NETWORK WITHOUT CAUSING DAMAGE. IT WAS OBSERVED DURING GRASPING THAT THE GRIPPER WAS NOT LANDING ON THE CLIP ARM CORRECTLY. WHILE IN THE ATRIUM, IT WAS NOTED THAT THE CLIP WAS UNABLE TO CLOSE. A SNARE WAS USED TO CLOSE AND REMOVE THE CLIP. THEREFORE, THE CLIP WAS REPLACED AND THREE CLIPS WERE THEN IMPLANTED, REDUCING THE TR TO A GRADE OF 1-2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080688 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL 40207R1005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention TRICLIP STEERABLE GUIDE CATHETER