BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 13633333 · Received March 1, 2022

    Report

    Report Number
    3005580113-2022-00032
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    January 28, 2022
    Report Date
    March 1, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME - QAN.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: COMMON NAME - QAN.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER: "TODAY I WAS MADE AWARE OF AN INCIDENT THAT OCCURRED AS A RESULT OF A ZILVER VENA C57449 (16X140) STENT THAT WAS PLACED BY (SURGEON)L AT C43414-4 ON (B)(6) 2022. THE STENT WAS PLACED VIA FEMORAL ACCESS WITHOUT INCIDENT HOWEVER UPON ARRIVAL HOME THE PATIENT EXPERIENCED SHORTNESS OF BREATH. HE WAS SENT TO THE HOSPITAL WHERE IT WAS DETERMINED THAT THE STENT HAD MIGRATED TO THE PATIENT¿S LUNGS. AN EMERGENCY SURGICAL PROCEDURE WAS PERFORMED BY A CARDIOTHERACIC SURGEON TO REMOVE THE STENT. ADDITIONAL SUBSEQUENT PROCEDURES MAY ALSO NEED TO BE PERFORMED HOWEVER THE PATIENT IS STABLE AND WALKING AROUND POST SURGERY."

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER: "TODAY I WAS MADE AWARE OF AN INCIDENT THAT OCCURRED AS A RESULT OF A ZILVER VENA C57449 (16X140) STENT THAT WAS PLACED BY (SURGEON)L AT C43414-4 ON (B)(6) 2022. THE STENT WAS PLACED VIA FEMORAL ACCESS WITHOUT INCIDENT HOWEVER UPON ARRIVAL HOME THE PATIENT EXPERIENCED SHORTNESS OF BREATH. HE WAS SENT TO THE HOSPITAL WHERE IT WAS DETERMINED THAT THE STENT HAD MIGRATED TO THE PATIENT¿S LUNGS. AN EMERGENCY SURGICAL PROCEDURE WAS PERFORMED BY A CARDIOTHERACIC SURGEON TO REMOVE THE STENT. ADDITIONAL SUBSEQUENT PROCEDURES MAY ALSO NEED TO BE PERFORMED HOWEVER THE PATIENT IS STABLE AND WALKING AROUND POST SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940462 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57449 C1829820 10827002574493

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| L