BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVASC 6.0 X 44 MM - FLOW RESTORATION, 3 DROP ZONES - 200 CM WIRE SYSTEM

    MDR report key: 22649127 · Received July 29, 2025

    Report

    Report Number
    3014498720-2025-00002
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 23, 2025
    Manufacturer
    VESALIO, INC.
    Product Code
    QEW
    UDI-DI
    00851279008514
    PMA / PMN Number
    K201085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PVASC 6.0X44 EXPANDABLE TIP DETACHED DURING A PROCEDURE WHILE ATTEMPTING TO WITHDRAW THE DEVICE THROUGH A STENTED REGION OF THE BLOOD VESSEL. IT WAS OBSERVED THAT THE EXPANDABLE TIP GOT STUCK ON THE STRUT OF THE STENT. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO WITHDRAW THE DETACHED TIP. HE DECIDED TO COMPRESS THE EXPANDABLE TIP AGAINST THE WALL OF THE ARTERY USING A NEW STENT. FOLLOWING THE DEVICE DETACHMENT AND PLACEMENT OF NEW STENT, THE PATIENT REMAINED CLINICALLY STABLE AND WAS DISCHARGED WITHOUT ANY NEGATIVE AFTER-EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827230 PVASC 6.0 X 44 MM - FLOW RESTORATION, 3 DROP ZONES - 200 CM WIRE SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY QEW VESALIO, INC. VP-6044-F3RR 032125B 00851279008514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown