BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ PTA BALLOON CATHETER

    MDR report key: 2073082 · Received April 29, 2011

    Report

    Report Number
    2183870-2011-00085
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    EV3 INC.
    Product Code
    NIN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN ATTEMPTED SMA ORIGIN STENTING. THERE WAS NO PRE-DILATATION PERFORMED BEFORE THE PHYSICIAN WENT TO DEPLOY THE VISI-PRO STENT. THE BALLOON FOR THE VISI-PRO BECAME LODGED INTO THE LESION AND IN AN ATTEMPT TO ADVANCE THE BALLOON, IT WAS PUSHED FARTHER INTO THE SMA. AN ATTEMPT TO RE-WIRE THE LESION WAS UNSUCCESSFUL AND THE PATIENT WAS SENT TO SURGERY FOR FEM-SMA BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO¿ PTA BALLOON CATHETER STENT, RENAL NIN EV3 INC. PXB35-05-17-080 9031804

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention .035 GLIDEWIRE| 6F BALKIN SHEATH