BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 3902485 · Received June 30, 2014

    Report

    Report Number
    9616099-2014-00426
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING FILTER PLACEMENT AN OPTEASE FILTER WAS PLACED IN THE RENAL VEIN INSTEAD OF THE INFERIOR VENA CAVA (IVC) AS INTENDED. APPROACH WAS MADE FROM JUGULAR VEIN AND THE OPTEASE FILTER WAS MISTAKENLY PLACED IN RENAL VEIN. IT WAS DETERMINED THAT RETRIEVAL OF THE FILTER WOULD BE TOO DIFFICULT SO THE FILTER WAS LEFT IN THE RENAL VEIN. A NEW OPTEASE FILTER WAS PLACED IN THE IVC FOR THE INDICATION OF DVT. THE EXTENT OF THE DVT IS UNKNOWN. THERE WAS NO THROMBUS PRESENT AT THE DELIVERY SITE. THERE IS NO FURTHER INFORMATION AVAILABLE. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE FILTER MISPLACEMENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR FILTER INSERTION DVT. IT IS UNKNOWN HOW IT WAS DOCUMENTED OR THE EXTENT OF THE DVT. THERE WAS NO THROMBUS PRESENT AT THE DELIVERY SITE. ANTICOAGULATION THERAPY, CONTRAINDICATION FOR ANTICOAGULATION AND RECURRENT PE IN SPITE OF ANTICOAGULATION WERE ALL UNKNOWN. THERE WAS NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING FILTER PLACEMENT, AN OPTEASE FILTER WAS PLACED IN THE RENAL VEIN INSTEAD OF THE TARGET LESION IN THE IVC. APPROACH WAS MADE FROM JUGULAR VEIN AND OPTEASE FILTER PLACEMENT WAS ATTEMPTED. HOWEVER, THE FILTER WAS MISTAKENLY PLACED IN RENAL VEIN. IT SEEMS DIFFICULT TO RETRIEVE THE FILTER, REMOVAL IS NOT ATTEMPTED AND A NEW OPTEASE FILTER WAS PLACED IN THE IVC INSTEAD. THERE WAS NO SYMPTOMS TO THE PATIENT REGARDING THE MISPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380798 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA 11106769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S