BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORSIRO 3.5/30

    MDR report key: 18946546 · Received March 20, 2024

    Report

    Report Number
    1028232-2024-01567
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 4, 2024
    Report Date
    October 24, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIQ
    UDI-DI
    07640130411807
    PMA / PMN Number
    P170030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES, CORRECTED THE INITIAL REPORTER INFORMATION. REFERENCE CAPA# NC-24-004. 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 IN QUESTION 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.

    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 IN QUESTION 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.

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES.

    Description of Event or Problem · 0

    AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (89 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS MID LAD. DESPITE PRE-DILATATION, THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699697 ORSIRO 3.5/30 CORONARY DRUG-ELUTING STENT NIQ BIOTRONIK AG, BUELACH, SWITZERLAND 364515 04224057 07640130411807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown