BEUDAMED
    FDA Adverse Event Death Summary report: N

    A.L.N.

    MDR report key: 8314201 · Received February 7, 2019

    Report

    Report Number
    3007080617-2019-00001
    Event Type
    Death
    Date Received
    February 7, 2019
    Date of Event
    January 18, 2019
    Report Date
    June 29, 2020
    Manufacturer
    A.L.N. IMPLANTS CHIRURGICAUX
    Product Code
    DTK
    PMA / PMN Number
    K163699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    57-YEAR-OLD 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 CAVA FILTER. PATIENT WAS DISCHARGED ON (B)(6) 2019. AFTER DISCHARGE, PATIENT WAS FOUND DECEASED. AUTOPSY WAS REQUESTED BY PATIENTS FAMILY. ANATOMIC PRELIMINARY DIAGNOSIS FOUND RETROPERITONEAL HEMORRHAGE (A. RIGHT RETROPERITONEAL HEMATOMA, B. 6 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.

    Description of Event or Problem · 1

    PRELIMINARY RESULTS WHICH SHOWED A POSSIBLE PIERCED IVC FROM AN ALN IVC FILTER WHICH RESULTED IN THE DEATH ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108049 A.L.N. VENA CAVA FILTER DTK A.L.N. IMPLANTS CHIRURGICAUX

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death