BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY G2 INFERIOR VENACAVA FILTER

    MDR report key: 3040060 · Received April 1, 2013

    Report

    Report Number
    MW5029620
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CR BARD
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SVC FILTER PLACED FOR UE DVT AT OUTSIDE INSTITUTION. PT HAD A CHEST PAIN EVENT 1 YR LATER. DURING CARDIAC CATHETERIZATION, FILTER WAS NOTED TO BE FRACTURED AND AN UPPER ARM STRUT WAS EMBOLIZED INTO THE RIGHT VENTRICLE. SVC FILTER WAS REMOVED PERCUTANEOUSLY (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132391 RECOVERY G2 INFERIOR VENACAVA FILTER G2 IVC FILTER DTK CR BARD G2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R