BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD LIFESTREAM COVERED STENT

    MDR report key: 20586689 · Received October 31, 2024

    Report

    Report Number
    MW5162005
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 24, 2024
    Report Date
    October 25, 2024
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD
    Product Code
    PRL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIOVASCULAR INTERVENTIONALIST WAS TRYING TO DEPLOY A COVER STENT (BARD LIFESTREAM). THE STENT DID NOT EXPAND COMPLETELY AND REQUIRED THE INTERVENTIONALIST TO RETRIEVE IT WITH SNARE TO PREVENT SERIOUS COMPLICATION, INCLUDING DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91484 BARD LIFESTREAM COVERED STENT ILIAC COVERED STENT, ARTERIAL PRL CLEARSTREAM TECHNOLOGIES LTD CMHS0406

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention