BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 20128215 · Received September 3, 2024

    Report

    Report Number
    3015537318-2024-00073
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    May 31, 2024
    Report Date
    September 3, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PSEUDOANEURYSM IS A KNOWN COMPLICATION THAT IS LISTED ON THE LABELING OF THE INTERA 3000 IFU. THE HEALTH INFORMATION PROVIDED DOES NOT ALLEGE A DEFICIENCY IN THE DEVICE PERFORMANCE, PACKAGING OR LABELING. IF FURTHER INFORMATION IS RECEIEVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS EXPLANTED. THE RECORD OF REPORT STATED THE FOLLOWING: PATIENT WAS STAGE 1B INTRAHEPATIC CHOLANGIOCARCINOMA IN THE LLS RESECTED IN AUGUST 2021 WITH ADJUVANT CAPE X3 MONTHS (STOPPED EARLY FOR SKIN TOXICITY). SHE HAD ISOLATED RECURRENCE IN SEG 4A IN 2022 WITH ABLATION OF THAT RECURRENCE. SHE WAS READMITTED TO THE HOSPITAL ON (B)(6) 2024 AND WAS FOUND TO HAVE A GDA (GASTRODUODENAL ARTERY) PSEUDOANEURYSM LIKELY FROM THE CATHETER INSERTION SITE AFTER HAVING HEMOBILIA. ON (B)(6) 2024, SHE UNDERWENT EMBOLIZATION OF THE GDA STUMP. AS RESULT THE PUMP IS NOT LONGER USABLE. ADDITIONALLY, SHE HAD AN INDURATED AREA ALONG THE LATERAL ASPECT OF HER SUBCOSTAL INCISION THAT IS PAINFUL WITH DEEP RESPIRATION AND ON PALPATION. DEVICE WAS EXPLANTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899789 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28521740 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H