BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 21893040 · Received April 23, 2025

    Report

    Report Number
    3015537318-2025-00042
    Event Type
    Injury
    Date Received
    April 23, 2025
    Report Date
    April 23, 2025
    Manufacturer
    INTERA ONCOLOGY
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT IDENTIFIED IN THE LITERATURE BUT IS ASSUMED TO BE INTERA 3000 HEPATIC ARTERY INFUSION PUMP. THE INTERA 3000 IS INDICATED FOR THE REGIONAL DELIVERY OF INFUSATES INCLUDING FLOXURIDINE. BLANK SPACES IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING PREPARATION FOR THE FDA ANNUAL REPORT, THE FOLLOWING LITERATURE WAS REVIEWED: ROBOTIC BILIARY STRICTUROPLASTY AND ROUX-EN-Y HEPATICOJEJUNOSTOMY AFTER HEPATIC ARTERY INFUSION PUMP INJURY. SHAPERA E, ROSS S, PATTILACHAN T, CHRISTODOULOU M, SUCANDY I.ANN SURG ONCOL. 2024 JUL;31(7):4449-4451. DOI: 10.1245/S10434-024-15258-0. EPUB 2024 APR 17.PMID: 38632219 ABSTRACT: HEPATIC ARTERY INFUSION PUMP (HAIP) WITH FLOXURIDINE/DEXAMETHASONE AND SYSTEMIC CHEMOTHERAPY IS AN ESTABLISHED TREATMENT REGIMEN, WHICH HAD BEEN REPORTED ABOUT CONVERTING 47% OF PATIENTS WITH STAGE 4 COLORECTAL LIVER METASTASIS FROM UNRESECTABLE TO RESECTABLE. TO THIS EFFECT, HAIP CHEMOTHERAPY CONTRIBUTES TO PROLONGED SURVIVAL OF MANY PATIENTS, WHICH OTHERWISE MAY NOT HAVE OTHER TREATMENT OPTIONS. BILIARY SCLEROSIS, HOWEVER, IS A KNOWN COMPLICATION OF THE HAIP TREATMENT, WHICH OCCURS IN APPROXIMATELY 5.5% OF PATIENTS RECEIVING THIS MODALITY AS AN ADJUVANT THERAPY AFTER HEPATECTOMY AND IN 2% OF PATIENTS RECEIVING HAIP TREATMENT FOR UNRESECTABLE DISEASE. WHILE BILIARY SCLEROSIS DIFUSELY AFECTS THE PERIHILAR AND INTRAHEPATIC BILIARY TREE, A DOMINANT STRICTURE MAYBE FOUND IN SELECT CASES, WHICH GIVES AN OPPORTUNITY FOR A LOCAL SURGICAL TREATMENT AFTER FAILURE OF ENDOSCOPIC STENTING/DILATIONS. WHILE THE USE OF MINIMALLY INVASIVE APPROACH TO BILIARY SURGERY IS GRADUALLY INCREASING, THERE HAVE BEEN NO DESCRIPTIONS OF ITS APPLICATION IN THIS SCENARIO. IN THIS VIDEO, WE DEMONSTRATE THE USE OF MINIMALLY INVASIVE ROBOTIC TECHNIQUE FOR BILIARY STRICTUROPLASTY AND ROUX-EN-Y (RY) HEPATICOJEJUNOSTOMY TO TREAT PERSISTENT RIGHT HEPATIC DUCT STRICTURE AFTER HAIP CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258325 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY AP-03000H 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention