BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2111048 · Received June 2, 2011

    Report

    Report Number
    9616099-2011-00373
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 5, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. THE PATIENT HAD AN OPTEASE FILTER PLACED IN THE VENA CAVA DUE TO SCHEDULED SPINAL SURGERIES. THE PATIENT WAS PRESCRIBED A 50MG FENTANYL PATCH AS TREATMENT FOR PAIN RESULTING FROM THE SPINAL SURGERIES. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, A SURGERY WAS SCHEDULED WHERE THE PATIENT WAS HOSPITALIZED TO REMOVE THE OPTEASE FILTER WITH RESULTS THAT SHOWED THE FILTER WAS EMBEDDED, THEREFORE, IT WAS UNABLE TO BE REMOVED. THE IFU NOTES THAT THE OPTEASE FILTER CAN BE SAFELY RETRIEVED UP TO 14 DAYS IN PATIENTS WHO NO LONGER REQUIRE PROTECTION AGAINST PULMONARY EMBOLISM. ATTEMPTED REMOVAL AT 4 MONTHS IS WELL OUTSIDE OF THIS RANGE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. THE RETRIEVAL DIFFICULTY EXPERIENCED BY THE COSTUMER WAS MOST LIKELY RELATED TO THE LENGTH OF TIME THE FILTER WAS DEPLOYED IN THE PATIENT. THE IFU STATES THAT THE INDICATION IS FOR UP TO 23 DAYS (CE MARK) 14 DAYS (USA). USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. THE PATIENT HAD AN OPTEASE FILTER PLACED IN THE VENA CAVA DUE TO SCHEDULED SPINAL SURGERIES. THE PATIENT WAS PRESCRIBED A 50MG FENTANYL PATCH AS TREATMENT FOR PAIN RESULTING FROM THE SPINAL SURGERIES. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE A SURGERY WAS SCHEDULED WHERE THE PATIENT WAS HOSPITALIZED TO REMOVE THE OPTEASE FILTER WITH RESULTS THAT SHOWED THE FILTER WAS EMBEDDED, THEREFORE, IT WAS UNABLE TO BE REMOVED. THE EVENT REMAINED ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening