BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPER X

    MDR report key: 21438185 · Received February 21, 2025

    Report

    Report Number
    2032493-2025-00151
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    October 11, 2024
    Report Date
    February 21, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NIM
    UDI-DI
    00842429111819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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). A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASPER X CAROTID STENT WAS USED TO TREAT A PATIENT WITH TANDEM OCCLUSION, ATHEROSCLEROTIC PLAQUE AT THE COMMON CAROTID ARTERY (CCA) - INTERNAL CAROTID ARTERY (ICA) BIFURCATION. VESSEL DIAMETER MEASURED 9MM PROXIMAL AND 2MM DISTAL. PERI-PROCEDURE DAPT TIROFIBAN AND POST-PROCEDURE DAPT CLOPIDOGREL WERE ADMINISTERED. REPORTEDLY, AFTER THE STENT DEPLOYMENT, THERE WAS WALL-ADHERENT THROMBUS FORMATION DESPITE INTRAVENOUS ASA. ASPIRATION WAS PERFORMED BUT NOT ALL THROMBUS MATERIAL COULD BE REMOVED AND TIROFIBAN WAS GIVEN AND COULD DISSOLVE THE THROMBUS. PATIENT OUTCOME AND CURRENT STATUS DESCRIBED AS "TEMPORALLY DISORIENTED, NIHSS 3, MRS 2."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471974 CASPER X STENT, CAROTID NIM MICROVENTION, INC. XCPR-0840-143RX-ME 0000413118 00842429111819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention