BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY FILTER SYSTEM

    MDR report key: 1211127 · Received October 23, 2008

    Report

    Report Number
    2020394-2008-00297
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    August 20, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS FILTER STATES: POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: FILTER FRACTURE. FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF THE FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. MOST CASES, HOWEVER, HAVE BEEN REPORTED WITHOUT ANY ADVERSE CLINICAL SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAINS. REPORTEDLY, THE PATIENT HAD RECEIVED AN IVC FILTER FOUR YEARS PRIOR, AFTER SUFFERING SEVERE LEG INJURIES FROM A MOTORCYCLE ACCIDENT. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR OPEN HEART SURGERY TO REMOVE A FILTER FRAGMENT THAT WAS ALLEGED TO BE IN HER HEART. THE PHYSICIAN'S DECISION WAS TO LEAVE THE IVC FILTER IN PLACE RATHER THAN REMOVING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention