BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 6/200/135

    MDR report key: 23800884 · Received December 15, 2025

    Report

    Report Number
    8043892-2025-12051
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 4, 2025
    Report Date
    January 29, 2026
    Manufacturer
    BIOTRONIK AG
    Product Code
    NIP
    UDI-DI
    07640130447042
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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 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 MODERATELY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE PROXIMAL FEMORAL ARTERY. AFTER PRE-DILATATION, THE PULSAR-18 T3 STENT SYSTEM COULD NOT PASS THE LESION.

    Description of Event or Problem · 0

    THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE PROXIMAL FEMORAL ARTERY. AFTER PRE-DILATATION, THE PULSAR-18 T3 STENT SYSTEM COULD NOT PASS THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272787 PULSAR-18 T3 6/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG 430506 06251939 07640130447042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown