BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION

    MDR report key: 14521956 · Received May 26, 2022

    Report

    Report Number
    MW5109949
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 15, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ANGIOTECH OPTION WAS IMPLANTED, VENA CAVA FILTER ON (B)(6) 2010. IVC EVALUATED BY CT ABDOMEN AND PELVIS WITHOUT CONTRAST ON APRIL 15, 2022 POSTERIOR PRONGS OUT OF LUMEN, ABUTTING L3 VERTEBRAL BODY, AORTA AND INTESTINE. VC STENOSIS AT FILTER. MIGRATION OF IBC OUTSIDE LUMEN. PLAN: ON 5/20/2022 RETRIEVAL OF INFERIOR VENA CAVA FILTER, POSSIBLE VENOGRAM WITH POSSIBLE VENOPLASTY, POSSIBLE AORTOGRAM WITH POSSIBLE ANGIOPLASTY OR STENTING. ANGIOTECH OPTION IMPLANTED, INFERIOR VENA CAVA FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160747 OPTION FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK ARGON MEDICAL DEVICES INC. 352506070

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Disability| L| O| H ATENOLOL 50 MG TAB| B COMPLEX | BLOOD GLUCOSE METER | CERTIRIZINE HCL TAB| FAMOTIDINE 20 MG TABLET | GLUCOSE BLOOD TEST STRIP | LANCETS | MAGNESIUM CITRATE | NARATRIPTAN 1 MG TAB| NIFEDIPINE 30 MG CONTROLLED-RELEASE TABLET| NORTRIPTYLINE 10 MG CAPSULE | NUEDEXTA 20-10 MG CAPS CAPSULE| POLYETHYLGLYCOL-PROPYL GLYCOL 0.4-0.3%| RIMEGEPANT TAB| VITAMINS