BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 1790938 · Received August 10, 2010

    Report

    Report Number
    9610978-2010-00152
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 20, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DUE TO THE PAUCITY OF CLINICAL INFORMATION AND IMAGE PROVIDED REGARDING THE FILTER, THE EXACT ETIOLOGY OF THE FILTER FRACTURE CANNOT BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PLEASE NOTE THAT THE CATALOG CODE (466FXXXX), REPRESENTS AN UNKNOWN OPTEASE VENA CAVA FILTER. THE CATALOG AND LOT NUMBER/(S) FOR THE ACTUAL PRODUCT/(S) USED IN THE PROCEDURE ARE UNKNOWN. INVESTIGATION WAS CONDUCTED, BUT THE INFORMATION WILL NOT BE AVAILABLE.

    Description of Event or Problem · 1

    THE PHYSICIAN NOTICED A BREAK ON THE FIRST VENOGRAM BEFORE ANY ATTEMPT WAS MADE TO REMOVE FILTER. THE OPTEASE FILTER HAD A BROKEN NITINOL BAR THAT WAS IN A TRANSVERSE LOCATION. DURING ATTEMPTS TO REMOVE THE FILTER, THE BAR COULD NOT BE MOVED TO A LONGITUDINAL POSITION. THE FILTER WAS UNABLE TO BE RETRIEVED. A PICTURE WAS PROVIDED. THE FILTER WAS IMPLANTED AT ANOTHER INSTITUTION, THEREFORE THE PRODUCT, PATIENT, OR IMPLANT INFORMATION WERE AVAILABLE. PICTURE RETURNED FROM THE ACCOUNT CONFIRMS ONE STRUT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening