BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPER X

    MDR report key: 21360269 · Received February 11, 2025

    Report

    Report Number
    2032493-2025-00119
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    November 23, 2024
    Report Date
    February 18, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NIM
    UDI-DI
    00842429111819
    PMA / PMN Number
    P170013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCE'S ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT.

    Additional Manufacturer Narrative · 0

    THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORT DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE US. THIS COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO CASPER CAROTID STENT - PMA# P210030).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OCCLUSION OF THE STENT IN THE 40 HOURS LATER OF THE IMPLANT.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE CORRECTIONS IN THE FOLLOWING SECTIONS: D1, D2A, D2B, G5 AND ADDITIONAL INFORMATION PROVIDED IN H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903778 CASPER X STENT, CAROTID NIM MICROVENTION, INC. XCPR-0840-143RX-ME 0000420731 00842429111819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other