BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2002464 · Received February 28, 2011

    Report

    Report Number
    9610978-2011-00040
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    February 1, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS LEFT BLANK BECAUSE ONLY THE MONTH AND YEAR ((B)(6) 2011) IS KNOWN. THE PROCEDURE DATE WAS LEFT BLANK BECAUSE ONLY THE MONTH AND YEAR ARE KNOWN ((B)(6) 2010). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ON 2009-(B)(6), THE PATIENT HAD AN OPTEASE FILTER PLACED IN AN UNKNOWN VESSEL DUE A CAESAREAN SECTION THAT RESULTED IN THROMBOSIS. THE PATIENT WAS ADVISED TO MINIMIZE ACTIVITY AND AVOID HEAVY LIFTING BECAUSE OF THE FILTER. ON 2011-(B)(6) THE PATIENT HAD SCHEDULED TESTING THAT INCLUDED ROENTGEN PHOTOGRAPHY THAT SHOWED A FILTER FRACTURE FURTHER DESCRIBED AS "ONE ARM OF THE FILTER WAS BROKEN ON THE INSIDE OF THE FILTER." THE PHYSICIAN WAS AWARE. AS TREATMENT, THE PATIENT WAS TO CONTINUE TO AVOID ACTIVITY THAT COULD FURTHER DAMAGE THE FILTER. 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. CLINICAL STUDY DATA AND A REVIEW OF PUBLISHED LITERATURE SUPPORTS THE SAFETY AND PERFORMANCE OF VENA CAVA FILTERS WHEN USED AS INTENDED. THE SAFETY PROFILE AND TYPES/INCIDENCES OF COMPLICATIONS REPORTED IN THE LITERATURE WERE CONSISTENT WITH HAZARDS IDENTIFIED IN THE PRODUCT RISK ASSESSMENTS, WITH REPORTED COMPLAINTS SINCE PRODUCT INTRODUCTION WORLDWIDE, AND WITH KNOWN HAZARDS IDENTIFIED FOR THESE TYPES OF DEVICES. ALTHOUGH REPORTS OF ADVERSE CLINICAL SEQUELAE FROM FILTER FRACTURES ARE RARE, FILTER FRACTURE IS A POTENTIAL COMPLICATION OF VENA CAVA FILTERS DURING BOTH DEPLOYMENT AND IMPLANTATION. ANATOMIC LOCATIONS THAT CREATE CONCENTRATED STRESS POINTS FROM FILTER DEFORMATION (FOR EXAMPLE, DEPLOYMENT AT APEX OF SCOLIOSIS, OVERLAPPING OF EITHER OF THE RENAL OSTIA, OR PLACEMENT ADJACENT TO A VERTEBRAL OSTEOPHYTE) MAY CONTRIBUTE TO FRACTURE OF A PARTICULAR FILTER STRUT. DUE TO THE PAUCITY OF CLINICAL INFORMATION PROVIDED REGARDING THE FILTER, THE EXACT ETIOLOGY OF THE FILTER FRACTURE CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    A HUSBAND SENT AN E-MAIL ON (B)(6) 2011 ON THE BEHALF OF A PATIENT TO INQUIRE ABOUT MEDICAL INFORMATION. ON (B)(6) 2009, THE PATIENT HAD AN OPTEASE FILTER PLACED IN AN UNKNOWN VESSEL DUE A CAESAREAN SECTION THAT RESULTED IN THROMBOSIS. THE PATIENT WAS ADVISED TO MINIMIZE ACTIVITY AND AVOID HEAVY LIFTING BECAUSE OF THE FILTER. ON (B)(6) 2011, THE PATIENT HAD SCHEDULED TESTING THAT INCLUDED ROENTGEN PHOTOGRAPHY THAT SHOWED A FILTER FRACTURE FURTHER DESCRIBED AS "ONE ARM OF THE FILTER WAS BROKEN ON THE INSIDE OF THE FILTER." THE PHYSICIAN WAS AWARE. AS TREATMENT, THE PATIENT WAS TO CONTINUE TO AVOID ACTIVITY THAT COULD FURTHER DAMAGE THE FILTER. THE EVENT REMAINED ONGOING. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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