BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2704915 · Received August 17, 2012

    Report

    Report Number
    9616099-2012-00435
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    November 3, 2011
    Report Date
    July 20, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 13 COMPLAINTS OF TILT AND APEX ABUTTING WITH THE CORDIS OPTEASE FILER WITHIN 13 SEPARATE PATIENTS FROM THE REFERENCED ARTICLE OF DEVICES WITH UNKNOWN CATALOG AND LOT NUMBERS. THE CATALOG AND LOT NUMBERS OF THE DEVICES ARE NOT AVAILABLE. THE PRODUCT INFORMATION LISTED REPRESENTS UNKNOWN OPTEASE FILTERS. THE CATALOG AND LOT NUMBERS OF THE DEVICES ARE NOT AVAILABLE. THE PRODUCT INFORMATION LISTED REPRESENTS AN UNKNOWN OPTEASE FILTER. THIS IS ONE OF 6 PRODUCTS ASSOCIATED WITH THE REPORTED EVENTS UNDER MANUFACTURER REPORT NUMBERS 9616099-2012-00435, 9616099-2012-00436, 9616099-2012-00437, 9616099-2012-00438, 9616099-2012-00439 AND 9616099-2012-00440.

    Additional Manufacturer Narrative · 1

    KESSEL ET AL; FIRST UK INFERIOR VENA CAVA FILTER REGISTRY REPORT 2011; REPORT THAT OF 166 OPTEASE AND 67 TRAPEASE FILTER PLACEMENTS IN A UK REGISTRY, THERE WERE 11 CASES OF TILTING WITH THE CORDIS OPTEASE FILER, 1 WITH THE TRAPEASE FILTER, 2 CASES OF APEX ABUTTING WITH THE OPTEASE, 1 CASE OF APEX ABUTTING WITH THE TRAPEASE, 1 CASE OF MIGRATION OF AN OPTEASE, ONE INSERTION DIFFICULTY IN WHICH AN OPTEASE WAS RETRIEVED IMMEDIATELY AFTER PLACEMENT BECAUSE OF PAIN, 7 CASES FOR POST FILTER DVT WITH THE OPTEASE (6 UNSPECIFIED), 3 CASES OF OPTEASE FILTER PE (10 UNSPECIFIED), 1 CASE OF TRAPEASE PE (4 UNSPECIFIED) AND 9 CASES OF OPTEASE RETRIEVAL DIFFICULTY. THE FILTERS WERE PLACED FROM 2008 TO 2010. THE MOST COMMONLY-RECORDED INDICATION FOR FILTER PLACEMENT IS PRE-OPERATIVE WITH ACUTE DVT / PE, FOLLOWED CLOSELY BY PE WITH CONTRA-INDICATION TO ANTICOAGULATION. THE MAJORITY OF PROCEDURES INVOLVED THE USE OF THE RIGHT FEMORAL OR RIGHT JUGULAR APPROACH. THE LEFT JUGULAR APPROACH WAS VERY RARELY USED. ALMOST TWO THIRDS OF PROCEDURES WERE COMPLETED WITHIN 30 MINUTES. SIGNIFICANTLY MORE PROCEDURES TOOK OVER 30 MINUTES WHEN USING THE LEFT FEMORAL VERSUS THE RIGHT JUGULAR APPROACH. THE VAST MAJORITY OF FILTERS ARE PLACED IN AN INFRA-RENAL OR JUXTA-RENAL LOCATION. OF THE 53 SUPRA-RENAL FILTER PLACEMENTS, 27 WERE FOR IVC THROMBOSIS AND 13 FOR PREGNANCY. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEWS COULD NOT BE PERFORMED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. 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. INCORRECT ORIENTATION OF THE FILTER IS A KNOWN COMPLICATION FOR FILTER PLACEMENT AS INDICATED IN THE IFU. THE TIMING, DEGREE AND MECHANISM OF THE REPORTED FILTER TILTS ARE UNCERTAIN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS, PATIENT FACTORS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 13 COMPLAINTS OF TILT AND APEX ABUTTING WITH THE CORDIS OPTEASE FILER WITHIN 13 SEPARATE PATIENTS FROM THE REFERENCED ARTICLE PREVIOUSLY SUBMITTED. THIS IS ONE OF 6 PRODUCTS ASSOCIATED WITH THE REPORTED EVENTS UNDER MANUFACTURER REPORT NUMBERS 9616099-2012-00435, 9616099-2012-00436, 9616099-2012-00437, 9616099-2012-00438, 9616099-2012-00439 AND 9616099-2012-00440.

    Description of Event or Problem · 1

    KESSEL ET AL; FIRST (B)(4) INFERIOR VENA CAVA FILTER REGISTRY REPORT 2011; REPORT THAT OF 166 OPTEASE AND 67 TRAPEASE FILTER PLACEMENTS IN A (B)(4) REGISTRY, THERE WERE 11 CASES OF TILTING WITH THE CORDIS OPTEASE FILER, 1 WITH THE TRAPEASE FILTER, 2 CASES OF APEX ABUTTING WITH THE OPTEASE, 1 CASE OF APEX ABUTTING WITH THE TRAPEASE, 1 CASE OF MIGRATION OF AN OPTEASE, ONE INSERTION DIFFICULTY IN WHICH AN OPTEASE WAS RETRIEVED IMMEDIATELY AFTER PLACEMENT BECAUSE OF PAIN, 7 CASES FOR POST FILTER DVT WITH THE OPTEASE (6 UNSPECIFIED), 3 CASES OF OPTEASE FILTER PE (10 UNSPECIFIED), 1 CASE OF TRAPEASE PE (4 UNSPECIFIED) AND 9 CASES OF OPTEASE RETRIEVAL DIFFICULTY. THE FILTERS WERE PLACED FROM 2008 TO 2010. THE MOST COMMONLY-RECORDED INDICATION FOR FILTER PLACEMENT IS PRE-OPERATIVE WITH ACUTE DVT / PE, FOLLOWED CLOSELY BY PE WITH CONTRA-INDICATION TO ANTICOAGULATION. THE MAJORITY OF PROCEDURES INVOLVED THE USE OF THE RIGHT FEMORAL OR RIGHT JUGULAR APPROACH. THE LEFT JUGULAR APPROACH WAS VERY RARELY USED. ALMOST TWO THIRDS OF PROCEDURES WERE COMPLETED WITHIN 30 MINUTES. SIGNIFICANTLY MORE PROCEDURES TOOK OVER 30 MINUTES WHEN USING THE LEFT FEMORAL VERSUS THE RIGHT JUGULAR APPROACH. THE VAST MAJORITY OF FILTERS ARE PLACED IN AN INFRA-RENAL OR JUXTA-RENAL LOCATION. OF THE 53 SUPRA-RENAL FILTER PLACEMENTS, 27 WERE FOR IVC THROMBOSIS AND 13 FOR PREGNANCY.

    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