BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 8716997 · Received June 19, 2019

    Report

    Report Number
    MW5087479
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 17, 2019
    Manufacturer
    TRYTON MEDICAL INC.
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STENT DISENGAGED SPONTANEOUSLY FROM DEPLOYMENT SYSTEM INSIDE CORONARY ARTERY. ANOTHER STENT WAS DEPLOYED IN AREA OF DISENGAGEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506281 TRYTON SIDE BRANCH STENT STENT, CORONARY MAF TRYTON MEDICAL INC. STENT LENGTH: 19MMX2.5MM SID - UBK21B1000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other