BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD LIFESTREAM BALLOON EXPANDABLE VASCULAR STENT

    MDR report key: 11404142 · Received March 2, 2021

    Report

    Report Number
    MW5099733
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 26, 2021
    Manufacturer
    CLEARSTREAM TECHNOLOGIES / BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PRL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TAVR, LIFESTREAM BALLOON EXPANDABLE VASC STENT INSERTED. ABOUT FIVE MINUTES LATER, STENT WAS FOUND TO HAVE COME OFF BALLOON IN BODY; STENT INSERTED AND ADVANCED TO FEMORAL. AFTER EXPLORATION, REMOVAL OCCURRED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299029 BARD LIFESTREAM BALLOON EXPANDABLE VASCULAR STENT ILIAC COVERED STENT, ARTERIAL PRL CLEARSTREAM TECHNOLOGIES / BARD PERIPHERAL VASCULAR, INC. 9MMX38MMX80CM CMCQ0366
    299030 BARD LIFESTREAM BALLOON EXPANDABLE VASCULAR STENT ILIAC COVERED STENT, ARTERIAL PRL CLEARSTREAM TECHNOLOGIES / BARD PERIPHERAL VASCULAR, INC. 8MMX26MMX80CM CMCS0439

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other