BEUDAMED
    FDA Adverse Event Death Summary report: N

    FILTER ALN FEMORAL

    MDR report key: 8358178 · Received February 7, 2019

    Report

    Report Number
    8358178
    Event Type
    Death
    Date Received
    February 7, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 7, 2019
    Manufacturer
    ADVANCED CRITICAL DEVICES, INC.
    Product Code
    DTK
    UDI-DI
    03760017680042
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH PAST MEDICAL HISTORY OF RECURRENT DEEP VEIN THROMBOSIS AND PULMONARY THROMBOEMBOLI, HYPERTENSION, AND COPD PRESENTED ON (B)(6) 2019 WITH COMPLAINT OF RIGHT UPPER QUADRANT ABDOMINAL PAIN AND WAS DIAGNOSED WITH ACUTE CHOLECYSTITIS. SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND PLACEMENT OF INFERIOR VENA CAVE FILTER. PT WAS DISCHARGED ON (B)(6) 2019. AFTER DISCHARGE, PT WAS FOUND DECEASED. AUTOPSY WAS REQUESTED BY PATIENT'S FAMILY. ANATOMIC PRELIMINARY DIAGNOSIS FOUND RETROPERITONEAL HEMORRHAGE (RIGHT RETROPERITONEAL HEMATOMA, SIX STRUTS OF AN INFERIOR VENA CAVA FILTER PERFORATING THE WALL OF THE INFERIOR VENA CAVA). THE AUTOPSY FINDINGS NOTED THAT THE CHOLECYSTECTOMY SURGICAL BED WAS FREE OF UNDUE HEMORRHAGE OR EVIDENCE OF INFECTION. THE AUTOPSY FINDINGS ARE PRELIMINARY. HISTOLOGIC EXAMINATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106846 FILTER ALN FEMORAL ALN VENA CAVA FILTER DTK ADVANCED CRITICAL DEVICES, INC. FF.HOOK 140416 03760017680042

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death