BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 3121812 · Received May 21, 2013

    Report

    Report Number
    9616099-2013-00312
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT DATE IS (B)(6) 2013. THE EXACT DATE IS UNKNOWN. COMPLAINT CONCLUSION: A PATIENT REPORTED VIA EMAIL THAT ¿I HAVE A CORDIS OPTEASE FILTER, IMPLANTED FOUR WEEKS AGO. MY DOCTOR TRIED TO REMOVE THE FILTER TODAY AND WAS UNABLE TO DO SO." NO OTHER INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) INDICATES AVAILABLE DATA FROM RETRIEVALS IN A 21 PATIENT STUDY AND A 40 PATIENTS RETROSPECTIVE CHART REVIEW SUGGEST THAT THE OPTEASE FILTER CAN BE SAFELY RETRIEVED (MEAN OF 11.1 DAYS, RANGE 5¿14 DAYS AND MEAN OF 16.4 DAYS, RANGE 3¿48 DAYS, RESPECTIVELY). PLEASE REFER TO THE CLINICAL EXPERIENCE SECTION OF THE IFU. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S IFU MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THE OPTEASE FILTER IS CONSIDERED A PERMANENT FILTER IF IT IS NOT RETRIEVED WITHIN A CLINICALLY SUITABLE TIME PERIOD. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT-CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT REPORTED VIA EMAIL THAT ¿I HAVE A CORDIS OPTEASE FILTER, IMPLANTED FOUR WEEKS AGO. MY DOCTOR TRIED TO REMOVE THE FILTER TODAY AND WAS UNABLE TO DO SO." NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224377 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1