BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTART VASCULAR STENT SYSTEM

    MDR report key: 3911625 · Received May 27, 2014

    Report

    Report Number
    9681442-2014-00085
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER HAS BEEN PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR STENT THAT WAS IMPLANTED IN (B)(6) 2013 IN THE SUBCLAVIAN VEIN SHOWED TWO FRACTURES DURING GUIDED FLUOROSCOPY. AN ANGIOPLASTY WAS PERFORMED TO FULLY EXPAND THE STENT. DURING ANGIOPLASTY, THE PTA BALLOON RUPTURED AND UPON REMOVAL A VERY SMALL SECTION OF THE VASCULAR STENT WAS ATTACHED TO THE PTA BALLOON. A CONTRAST INJECTION DEMONSTRATED NO EXTRAVASATION WITHIN OR NEAR THE VASCULAR STENT. THE SUBCLAVIAN VEIN WAS REPORTED TO BE PATENT WITH GOOD BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311423 LIFESTART VASCULAR STENT SYSTEM NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention