BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPER X

    MDR report key: 21440817 · Received February 22, 2025

    Report

    Report Number
    2032493-2025-00154
    Event Type
    Injury
    Date Received
    February 22, 2025
    Date of Event
    January 7, 2025
    Report Date
    April 20, 2025
    Manufacturer
    MICROVENTION INC.
    Product Code
    NIM
    UDI-DI
    00842429111833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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). THE DEVICE WAS IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    PROCEDURE/MEDICAL INFORMATION REVIEW: MEDICAL REPORT REVIEW: A DETAILED MEDICAL REVIEW OF THE EVALUATION FORMS FOR THE CASPER X 5F STENT DEVICE DATED (B)(6) 2024, WAS PERFORMED ON (B)(6) 2025. PATIENT RECEIVED TREATMENT FOR A TANDEM OCCLUSION WITH A CASPER X 5F STENT DEVICE WHICH FULLY OPENED INTRAOPERATIVELY. INDEX PROCEDURE DATE IS (B)(6) 2024. TWENTY-FOUR HOURS AFTER THE PERFORMANCE OF THE PROCEDURE, A POST PROCEDURE CASPER X 5F STENT OCCLUSION OCCURRED WHICH WAS TREATED WITH ASA & CLOPIDOGREL. THE PATIENTS POST-OPERATIVE CONDITION WAS REPORTED AS NO WORSENING OF THE CONDITION FROM THE TIME OF HOSPITAL ADMISSION AND THE NIHSS 16, MRS 5 WAS REPORTED. BASED ON A REVIEW OF THE AVAILABLE MEDICAL INFORMATION FORMS DATA AND IN MY PROFESSIONAL OPINION, A POST CASPER X 5F IMPLANTATION THROMBUS OCCURRED TWENTY-FOUR HOURS AFTER THE PERFORMANCE OF THE PROCEDURE AND THE RELATIONSHIP TO THE CASPER X 5F DEVICE CANNOT BE RULED OUT. NO DEVICE MALFUNCTION WAS REPORTED ASSOCIATED WITH THE CASPER X 5F DEVICE AND/OR NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE REPORTED THROMBUS. INVESTIGATION CONCLUSION: A MEDICAL REVIEW OF THE EVALUATION FORMS FOR THE CASPER X 5F STENT DEVICE WAS PERFORMED. BASED ON THE REVIEW OF THE AVAILABLE MEDICAL INFORMATION FORMS DATA, A POST CASPER X 5F IMPLANTATION THROMBUS OCCURRED TWENTY-FOUR HOURS AFTER THE PERFORMANCE OF THE PROCEDURE AND THE RELATIONSHIP TO THE CASPER X 5F DEVICE CANNOT BE RULED OUT. NO DEVICE MALFUNCTION WAS REPORTED ASSOCIATED WITH THE CASPER X 5F DEVICE AND/OR NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE REPORTED THROMBUS. WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CASPER X WAS USED DURING A TANDEM OCCLUSION PROCEDURE. THE PROCEDURE WENT WELL AND 24 HOURS AFTER THE PROCEDURE THE STENT WAS OCCLUDED. THE PATIENT RECEIVED DUAL ANTIPLATELET THERAPY, ASA & CLOPIDOGREL. THE PROCEDURE WAS COMPLETED WITH NO FURTHER TREATMENT. THE PATIENT WAS REPORTED TO BE THE SAME AS AT ADMISSION, NO WORSENING, NIHSS 16, MRS 5.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED, PLEASE SEE H6 & H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667098 CASPER X STENT, CAROTID NIM MICROVENTION INC. XCPR-0930-143RX-ME 0000402631 00842429111833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention