BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM

    MDR report key: 2994030 · Received March 5, 2013

    Report

    Report Number
    2994030
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    December 28, 2012
    Report Date
    March 5, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS AND MORBIDLY OBESE, WITH UPCOMING SURGERIES. THEREFORE, AN IVC FILTER ORDERED FOR THROMBOEMBOLIC PROPHYLAXIS.IMAGING OF FILTER SHOWED FILTER TO BE TILTED TO PATIENT'S RIGHT, PLACING THE FILTER APEX IN CONTACT WITH THE RIGHT LATERAL CAVAL WALL. FIBROUS CAP WAS PRESENT OVER THE FILTER HOOK. THERE WAS A MID-SHAFT LEG FRACTURE IN THE FILTER THAT WAS PRESENT ON CT SCAN FOR MORE THAN ONE YEAR. FILTER FRAGMENT WAS IDENTIFIED OVER THE RIGHT UPPER QUADRANT OF THE ABDOMEN. FILTER WAS REMOVED USING A LOOP SNARE TECHNIQUE. NO ADDITIONAL FILTER FRACTURES WERE IDENTIFIED. NO EVIDENCE OF THROMBUS IN THE INFERIOR VENA CAVA (IVC), IVC FILTER OR VISUALIZED ON THE INITIAL IVC-GRAM.======================MANUFACTURER RESPONSE FOR IVC FILTER, IVC FILTER (PER SITE REPORTER).======================NO RESPONSE AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS AND MORBIDLY OBESE, WITH UPCOMING SURGERIES. THEREFORE, AN IVC FILTER ORDERED FOR THROMBOEMBOLIC PROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93703 ECLIPSE FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD PERIPHERAL VASCULAR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR