BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA V12,COVERED STENT SYS,9X59X80

    MDR report key: 24799706 · Received April 7, 2026

    Report

    Report Number
    3011175548-2026-000003
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 24, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    UDI-DI
    00650862853292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6). THIS EVENT OCCURRED ON THE AUSTRALIA MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDID INFORMATION EXISTS. UDI INFORMATION PROVIDED IN D4 IS FOR THE ADVANTA STENT (OUS DEVICE). IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ICAST STENT WHICH IS SOLD IN THE USA UNDER PRIMARY DI NUMBER: 00650862489590, PREMARKET SUBMISSION NUMBER: P120003. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, E1- OCCUPATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON OF THE ADVANTA V12 STENT RUPTURED DURING DEPLOYMENT. THE BALLOON FAILURE OCCURRED PRIOR TO ACHIEVING THE INTENDED INFLATION LEVEL, WITH THE ESTIMATED PRESSURE AT THE TIME OF RUPTURE BEING BETWEEN 8 AND 12 ATM. THE STENT AND DELIVERY SYSTEM WERE SUCCESSFULLY RETRIEVED AS A SINGLE UNIT FROM THE PATIENT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587578 ADVANTA V12,COVERED STENT SYS,9X59X80 STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION 85329 473506 00650862853292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 7FR SHEATH.| UNKNOWN.