BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION IVC FILTER

    MDR report key: 2192684 · Received August 1, 2011

    Report

    Report Number
    MW5021603
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ANGIOTECH INTERVENTIONAL
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD AN OPTION IVC FILTER PLACED ON (B)(6) 2010. THE PRESENTED FOR ROUTINE REMOVAL OF THE FILTER ON (B)(6) 2011. THE TIP OF THE FILTER WAS EMBEDDED AGAINST THE WALL OF THE IVC AND COULD NOT BE ENGAGED WITH THE SNARE. MULTIPLE ATTEMPTS WERE MADE TO DISENGAGE THE FILTER TIP FROM THE CAVAL WALL. DURING ONE OF THESE ATTEMPTS, A NITINOL WIRE LOOP WAS SUCCESSFULLY ENGAGED AROUND 2 LEGS OF THE FILTER. THESE 2 LEGS BROKE OFF AND WERE SUCCESSFULLY REMOVED, LEAVING THE REMAINDER OF THE FILTER STILL WITHIN THE PT. AFTER MULTIPLE OTHER ATTEMPTS, THE REMAINDER OF THE IVC FILTER WAS SUCCESSFULLY REMOVED. DUE TO THE PROLONGED NATURE OF THE PROCEDURE, THE PT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THERE WERE NO APPARENT CLINICAL SEQUELAE, APART FROM A POSSIBLE GROIN HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTION IVC FILTER OPTION IVC FILTER DTK ANGIOTECH INTERVENTIONAL S31633

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability