BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPER 5F

    MDR report key: 21453917 · Received February 24, 2025

    Report

    Report Number
    2032493-2025-00156
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    December 25, 2024
    Report Date
    February 22, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NIM
    UDI-DI
    00842429111741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS IMPLANTED AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION BY THE MANUFACTURER. HOWEVER, MEDICAL INFORMATION WAS PROVIDED AND WILL BE REVIEWED. THE INVESTIGATION IS ONGOING AND UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE US. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO ROADSAVER/CASPER CAROTID STENT DEVICE ¿ PMA # P210030).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TREATMENT OF A DISSECTION. A SOLITAIRE AB STENT WAS USED FIRST, WAS NOT LONG ENOUGH TO COVER THE COMPLETE LESION. CASPER X WAS DEPLOYED IN TELESCOPING TECHNIQUE PROXIMAL TO SOLITAIRE. THERE WAS NO FLOW THOUGH BOTH STENTS. INTRAPROCEDURAL OCCLUSION OF CASPER X WHILE THE PATIENT WAS RECEIVING TIROFIBAN. NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414543 CASPER 5F STENT CAROTID NIM MICROVENTION, INC. XCPR-0630-143RX-ME 0000411612 00842429111741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown