BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENA TECH LP

    MDR report key: 1613785 · Received February 17, 2010

    Report

    Report Number
    1613785
    Event Type
    Other
    Date Received
    February 17, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 16, 2010
    Manufacturer
    BBRAUN
    Product Code
    DTK
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD UNREMARKABLE IVC FILTER INSERTION ON (B) (6) 2010. OPTIMAL POSITION WAS DOCUMENTED RADIOGRAPHICALLY. DURING AN UNRELATED CT SCAN ON (B) (6) 2010, IT WAS DISCOVERED THAT THE IVC FILTER HAD MIGRATED CRANIALLY TO THE INTRAHEPATIC IVC, JUST INFERIOR TO THE RIGHT ATRIUM. CT ALSO SHOWED LARGE RIGHT SIDED PE WHICH WAS NOT PRESENT ON EARLIER (B) (6) 2010 CT EXAM. HEPATIC AND UPPER/LOWER EXTREMITY VEIN DUPLEX SHOWED NO EVIDENCE OF SOURCE OF THROMBUS. UNK IF FILTER MIGRATION CAUSED PE. RADIOLOGIST SPOKE EXTENSIVELY WITH ALL (B) (6) DOCTORS AND THE PT'S MEDICAL TEAM. IT WAS DECIDED THAT IT WAS NOT ADVISABLE FOR IR TEAM TO INTERVENE. CARDIOVASCULAR SURGERY WAS CONSULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA TECH LP PERMANENT IVC FILTER DTK BBRAUN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR