BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 6644281 · Received June 15, 2017

    Report

    Report Number
    1625425-2017-00079
    Event Type
    Death
    Date Received
    June 15, 2017
    Date of Event
    May 18, 2015
    Report Date
    June 15, 2017
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DTK
    PMA / PMN Number
    K133243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND NO IMAGES OR VIDEOS HAVE BEEN PROVIDED OF THE FILTER IN-VIVO, SO THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, THIS ISSUE WILL BE REEVALUATED AS NEEDED. ¿DEVICE BREAKAGE OR FAILURE OR INABILITY TO RETRIEVE IMPLANTED DEVICE AS DESCRIBED IN IFU, POSSIBLY REQUIRING ANOTHER INTERVENTION OR TREATMENT MODALITY TO COMPLETE PROCEDURE¿, "DEATH", "FILTER MIGRATION/MOVEMENT", "INCORRECT POSITIONING OR ORIENTATION OF THE FILTER", "VENA CAVA OR OTHER VESSEL INJURY OR DAMAGE, INCLUDING RUPTURE OR DISSECTION, POSSIBLY REQUIRING SURGICAL REPAIR OR INTERVENTION", "THROMBOEMBOLIC EVENTS, INCLUDING DVT, ACUTE OR RECURRENT PULMONARY EMBOLISM OR AIR EMBOLISM, POSSIBLY CAUSING END ORGAN INFARCTION/DAMAGE/FAILURE", AND "INJURY OR DAMAGE TO ORGANS ADJACENT TO VENA CAVA, POSSIBLY REQUIRING SURGICAL REPAIR OR INTERVENTION" ARE POTENTIAL COMPLICATIONS CITED IN THE IFU ASSOCIATED WITH THIS PRODUCT. IN THE OPTIONAL PROCEDURE FOR FILTER RETRIEVAL SECTION OF THE IFU, IT STATES: ¿IF THE FILTER IS RETRIEVED, IT SHOULD BE DONE WITHIN 175 DAYS FOLLOWING IMPLANT.¿ THIS DEVICE CAN REMAIN PERMANENTLY IMPLANTED.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT FILED ON MAY 17, 2017, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2012 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6). SOMETIME THEREAFTER, THE FILTER WAS ALLEGEDLY NOTED TO BE ¿MALPOSITIONED AND DISLODGED. IT WAS FOUND TO BE LOCATED HORIZONTALLY IN THE LEFT RENAL VEIN AND NO LONGER EFFECTIVE IN PREVENTING PE. HOWEVER, DOCTORS DETERMINED THE FILTER COULD NOT BE PHYSICALLY REMOVED WITH MINIMALLY INVASIVE MEASURES AND THE RISK ASSOCIATED WITH ADJUSTING THE FILTER WAS TOO HIGH.¿ THE PATIENT DIED ON OR ABOUT (B)(6) 2015 ALLEGEDLY FROM ¿COMPLICATIONS DUE TO THE IMPLANTATION OF THE FILTER.¿ ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424814 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death