BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 2727062 · Received September 5, 2012

    Report

    Report Number
    3007566237-2012-02099
    Event Type
    Death
    Date Received
    September 5, 2012
    Date of Event
    July 14, 2012
    Report Date
    August 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATES OF DEATH AND EVENT DATES WERE NOT PROVIDED; THESE DATES ARE BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. THE INFORMATION IS THE AVERAGE FOR ALL PATIENTS. (B)(4).

    Description of Event or Problem · 1

    BAEK, Y. H., KIM, K. T., LEE, S. W., JEONG, J. S., PARK, B. H., NAM, K. J., CHO, J. H., KIM, Y. H., ROH, Y. H., LEE, H. S., CHOI, Y. M., HAN, S. Y. EFFICACY OF HEPATIC ARTERIAL INFUSION CHEMOTHERAPY IN ADVANCED HEPATOCELLULAR CARCINOMA. WORLD JOURNAL OF GASTROENTEROLOGY : WJG. 2012;18(26):3426-3434. DOI: 10.3748/WJG.V18.I26.3426. THE AIM WAS TO INVESTIGATE THE EFFICACY OF HEPATIC ARTERIAL INFUSION CHEMOTHERAPY (HAIC) USING FLOXURIDINE (FUDR) IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA (HCC) CONFINED TO THE LIVER. THIRTY-FOUR PATIENTS WHO HAD ADVANCED HCC WITH UNRESECTABILITY OR UNSUCCESSFUL PREVIOUS THERAPY IN THE ABSENCE OF EXTRAHEPATIC METASTASIS WERE TREATED WITH INTRA-ARTERIAL FUDR CHEMOTHERAPY AT OUR HOSPITAL BETWEEN (B)(6) 2005 AND (B)(6) 2008. AMONG THE 34 PATIENTS, 9 PATIENTS WERE CLASSIFIED AS CHILD CLASS C, AND 18 PATIENTS HAD PORTAL VEIN TUMOR THROMBUS (PVTT). ONE COURSE OF CHEMOTHERAPY CONSISTED OF CONTINUOUS INFUSION OF FUDR (0.3 MG/KG DURING DAY 1-14) AND DEXAMETHASONE (10 MG ON DAY 1, 4, 7 AND 11), AND THIS TREATMENT WAS REPEATED EVERY 28 D. TWO PATIENTS ((B)(4)) DISPLAYED A COMPLETE RESPONSE, AND 12 PATIENTS ((B)(4)) HAD A PARTIAL RESPONSE. THE TUMOR CONTROL RATE WAS (B)(4). THE MEDIAN OVERALL SURVIVAL TIMES WERE 15.3 MO, 12.4 MO AND 4.3 MO FOR THE PATIENTS WHO WERE CLASSIFIED AS CHILD CLASS A, CHILD CLASS B AND CHILD CLASS C, RESPECTIVELY (P = 0.0392). THE PROGRESSION-FREE SURVIVAL WAS 12.9 MO, 7.7 MO, AND 2.6 MO FOR THE PATIENTS WHO WERE CLASSIFIED AS CHILD CLASS A, CHILD CLASS B AND CHILD CLASS C, RESPECTIVELY (P = 0.0443). THE CUMULATIVE SURVIVAL DIFFERED SIGNIFICANTLY ACCORDING TO THE CHILD-PUGH CLASSIFICATION AND THE PRESENCE OF PVTT. IN ADDITION TO HEPATIC RESERVE CAPACITY AND PVTT, THE EXTENT OF HCC WAS AN INDEPENDENT FACTOR IN DETERMINING A POOR PROGNOSIS. THE MOST COMMON ADVERSE REACTIONS TO HAIC WERE MUCOSITIS, DIARRHEA AND PEPTIC ULCER DISEASE, BUT MOST OF THESE COMPLICATIONS WERE IMPROVED BY MEDICAL TREATMENT AND/OR A DELAY OF HAIC. THE PRESENT STUDY DEMONSTRATES THAT INTRA-ARTERIAL FUDR CHEMOTHERAPY IS A SAFE AND EFFECTIVE TREATMENT FOR ADVANCED HCC THAT IS RECALCITRANT TO OTHER THERAPEUTIC MODALITIES, EVEN IN PATIENTS WITH ADVANCED CIRRHOSIS. REPORTED EVENTS: 1 PATIENT WITH (B)(6) EXPERIENCED (B)(6) DURING THE THIRD CYCLE OF CHEMOTHERAPY; THE FUDR WAS WITHDRAWN. THE PATIENT EVENTUALLY DIED. DURING TREATMENT, 3 PATIENTS DIED OF HEPATIC FAILURE RELATED TO AN ADVANCED CIRRHOTIC CONDITION. TWO PATIENTS EXPERIENCED FEVER (GRADE 1-2). SEVEN PATIENTS DEVELOPED A GASTRIC OR DUODENAL ULCER (3 AT GRADE 1-2 AND 4 AT GRADE 3-4). SEVEN PATIENTS DEVELOPED MUCOSITIS (4 AT GRADE 1-2 AND 3 AT GRADE 3-4). SEVEN PATIENTS DEVELOPED DIARRHEA (4 AT GRADE 1-2 AND 3 AT GRADE 3-4). THREE PATIENTS DEVELOPED LEUKOPENIA (2 AT GRADE 1-2 AND 1 AT GRADE 3-4). THREE PATIENTS DEVELOPED THROMBOCYTOPENIA (2 AT GRADE 1-2 AND 1 AT GRADE 3-4). FIVE PATIENTS DEVELOPED ELEVATED BILIRUBIN (4 AT GRADE 1-2 AND 1 AT GRADE 3-4). SIX PATIENTS DEVELOPED AST/ALT ELEVATION (5 AT GRADE 1-2 AND 1 AT GRADE 3-4). ONE PATIENT EXPERIENCED BUN/CREATININE ELEVATION AT GRADE 3-4. ONE PATIENT EXPERIENCED A CATHETER INFECTION. THE INFECTION WAS CONTROLLED BY ANTIBIOTICS AND REMOVAL OF THE PORT. THE PATIENT CONTINUED HAIC AFTER INSERTION OF ANOTHER CATHETER IN THE OPPOSITE SITE. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Death| O| R CATHETER MODEL: UNK LOT/SERIAL#: UNK