BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 6/200/135

    MDR report key: 20903454 · Received December 11, 2024

    Report

    Report Number
    1028232-2024-06394
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 19, 2024
    Report Date
    February 12, 2025
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    UDI-DI
    07640130447042
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THIS EVENT. IN ADDITION, THE PROVIDED IMAGES AND THE PROVIDED VIDEO OF THE ANGIOGRAM WERE REVIEWED. THE PHOTOGRAPHS PROVIDED SHOWS THE SFA IN DIFFERENT STAGES OF THE INTERVENTION. NO DETAILS ABOUT GEOMETRICAL DISTORTIONS OF THE STENT ARE VISIBLE. THE VIDEO PROVIDED SHOWS THE POSITIONING AND THE RELEASE OF THE COMPLAINT STENT. IT IS VISIBLE, THAT THE RETRACTABLE SHAFT IS PULLED BACK, WHEREAS THE INNER SHAFT IS PUSHED FORWARD, RESULTING IN THE POSITION AT THE DISTAL END OF THE STENT TO BE CORRECT, WHEREAS THE POSITION OF THE PROXIMAL END OF THE STENT IS SHIFTED BY SEVERAL CENTIMETERS. THIS IS INDICATIVE FOR THE PRESENCE OF A SLACK IN THE DELIVERY SYSTEM OUTSIDE OF THE BODY DURING THE RELEASE ATTEMPT. THE TECHNICAL INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT THE STENT HAS BEEN FULLY RELEASED. THE OUTER SHAFT HAS BEEN RETRACTED BY ABOUT 232 MM. BESIDES A KINK 15 MM PROXIMAL TO THE DISTAL X-RAY MARKER NO DAMAGE OR IRREGULARITY WAS OBSERVED. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. BASED ON THE CONDUCTED INVESTIGATIONS NO MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED. THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT EVENT IS RELATED TO THE HANDLING DURING THE PROCEDURE. PLEASE NOTE THAT, ACCORDING TO THE IFU, ANY SLACK IN THE DELIVERY SYSTEM OUTSIDE THE PATIENT COULD RESULT IN INCORRECT STENT PLACEMENT, POTENTIAL STENT COMPRESSION OR ELONGATION.

    Description of Event or Problem · 0

    A PULSAR-18 T3 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT FOR A SEVERELY CALCIFIED LESION IN THE SFA. AT THE MOMENT OF THE DEPLOYMENT, AFTER HAVING PULLED BACK THE STENT BECAUSE OF MINOR PHYSIOLOGICAL JUMPING OF THE DEVICE WHEN RELEASING THE FIRST STRUTS, THE SHAFT STARTED MOVING DISTALLY, ENDING UP WITH COMPRESSION OF THE STENT AND PROXIMAL MISALIGNMENT/SHORTENING. THIS 6X200MM STENT WAS FINALLY DEPLOYED AT A LENGTH OF ROUGHLY 170MM. AN ADDITIONAL PULSAR 6X60MM WAS DEPLOYED PROXIMALLY TO COVER THE PROXIMAL DISEASED PART LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411497 PULSAR-18 T3 6/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 430506 03241820 07640130447042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown