BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORSIRO MISSION US 3.5/22

    MDR report key: 24019209 · Received January 9, 2026

    Report

    Report Number
    8043892-2025-12182
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BIOTRONIK AG
    Product Code
    NIQ
    UDI-DI
    07640130456099
    PMA / PMN Number
    P170030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES. 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 ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (89 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL RCA. PRE-DILATION OF THE LESION WAS PER-FORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE PHYSICIAN WAS ABLE TO CROSS THE LESION USING ANOTHER MANUFACTURERS STENT. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78561 ORSIRO MISSION US 3.5/22 CORONARY DRUG-ELUTING STENT NIQ BIOTRONIK AG 453953 04253775 07640130456099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown