BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 5/200/135

    MDR report key: 21764141 · Received April 3, 2025

    Report

    Report Number
    1028232-2025-01636
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 22, 2025
    Report Date
    May 12, 2025
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    UDI-DI
    07640130446946
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE AFFECTED DEVICE NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED. THEREFORE, NO TECHNICAL INVESTIGATION ON THE SUBJECT COULD BE PERFORMED. THE PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. IN ADDITION, A VIDEO TAKEN FROM THE ANGIOGRAM WAS REVIEWED. THE VIDEO PROVIDED SHOWS THREE RELEASED STENTS IN THE SFA. AT THE MIDDLE STENT, GEOMETRIC DISTORTIONS OF THE STENT STRUCTURE ARE RECOGNIZABLE. THE INHOMOGENEOUS RADIOPACITY AT THE DISTAL END OF THE STENT MAY BE SUGGESTIVE OF FOCAL STENT COMPRESSION OR ELONGATION. UNFORTUNATELY, THE QUALITY OF THE VIDEO IS RATHER POOR. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 0

    THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) A SEVERELY TORTUOUS PART OF THE PROXIMAL RIGHT VERTEBRAL ARTERY. AFTER PRE-DILATATION, THE PULSAR-18 WAS DELIVERED TO THE LESION AND RELEASED, BUT THE DISTAL AREA OF THE STENT WAS TWISTED AND SHORTENED AROUND 1 CM. A BALLOON WAS USED TO INFLATE THE TWISTED AREA, BUT THE STENT STRUCTURE WAS DAMAGED. ANOTHER STENT WAS IMPLANTED TO COVER THE DAMAGED AREA AND THE VESSEL WAS IMPROVED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575157 PULSAR-18 T3 5/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 430496 04243891 07640130446946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown