BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION CATHETER

    MDR report key: 2553283 · Received April 30, 2012

    Report

    Report Number
    3007566237-2012-00926
    Event Type
    Injury
    Date Received
    April 30, 2012
    Date of Event
    November 1, 2011
    Report Date
    April 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATE WAS NOT PROVIDED. THIS DATE IS BASED ON THE PUBLICATION DATE OF THE ARTICLE (DAY OF THE MONTH UNKNOWN). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENT REPORTED WITH A PREVIOUSLY REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: KANEKO J., ISOGAI J., YOSHIDA T., AOYAGI H., HASEGAWA K., KATSUTA E., TAKAHATA T., IWATA N., MAEJIMA S. "A CASE OF UNRESECTABLE MULTIPLE HEPATIC METASTASES FROM COLORECTAL CANCER SUCCESSFULLY TREATED WITH PANITUMUMAB THERAPY ON THIRD-LINE." (B)(6). 38(12) (2011): 2247-2249. PRINT. ABSTRACT: IN A PATIENT WITH MULTIPLE LIVER METASTASES OF COLORECTAL CANCER IN WHOM TUMOR RESPONSE HAD BEEN ACHIEVED BY 5-FU HEPATIC ARTERIAL INFUSION, THE CATHETER FOR ARTERIAL INFUSION CHEMOTHERAPY WAS OCCLUDED RESULTING IN RE-ELEVATION OF TUMOR MARKER LEVELS. SECOND-LINE IRIS THERAPY USING S-1 AND CPT-11 WAS STARTED. IRIS THERAPY REDUCED TUMOR MARKER LEVELS TO A DEGREE GREATER THAN THAT PREVIOUSLY ACHIEVED WITH 5-FU HEPATIC ARTERIAL INFUSION, AND DIAGNOSTIC IMAGING ALLOWED A JUDGMENT OF PARTIAL RESPONSE. BUT TUMOR MARKER LEVELS INCREASED GRADUALLY. AFTER ALL, DIAGNOSTIC IMAGING ALLOWED A JUDGMENT OF PROGRESSIVE DISEASE AND AN EMINENT ELEVATION OF TUMOR MARKER LEVELS IN ONE YEAR. THIRD-LINE PANITUMUMAB THERAPY WAS STARTED. PANITUMUMAB THERAPY REDUCED TUMOR MARKER LEVELS TO A DEGREE GREATER THAN THAT PREVIOUSLY ACHIEVED WITH 5-FU HEPATIC ARTERIAL INFUSION AND IRIS THERAPY, AND DIAGNOSTIC IMAGING ALLOWED A JUDGMENT OF PARTIAL RESPONSE. THE AUTHOR REPORT HEREIN A SUCCESSFUL CASE. HEPATIC ARTERIAL INFUSION THERAPY IS ONE OF THE TREATMENT METHODS CHARACTERIZED BY A LOWER INCIDENCE OF ADVERSE REACTIONS, RELATIVELY LOW COST, AND EXPECTATION OF HIGH ANTI-TUMOR EFFICACY AS COMPARED TO CHEMOTHERAPY SUCH AS FOLFIRI. IRIS THERAPY DOES NOT REQUIRE A PORT INSERTION AND PUMP CARRYING, AND ITS COST IS ABOUT (B)(6) OF FOLFIRI THERAPY. WHEN USED AS SECOND-LINE THERAPY FOR UNRESECTABLE COLORECTAL CANCER, NON-INFERIORITY OF IRIS THERAPY TO FOLFIRI THERAPY HAS BEEN DEMONSTRATED IN A PHASE II/III CLINICAL (L FIRIS) STUDY. WE MAY SAY THAT IRIS THERAPY IS PROMISING AS AN EQUIVALENT TO HEPATIC ARTERIAL INFUSION THERAPY IN THE TREATMENT OF LIVER METASTASES OF COLORECTAL CANCER. IN ADDITION, WE MAY SAY THAT PANITUMUMAB THERAPY IS PROMISING AS AN EQUIVALENT TO HEPATIC ARTERIAL INFUSION THERAPY AND IRIS THERAPY. REPORTED EVENT: POSTOPERATIVE HEPATIC ARTERIAL INFUSION TREATMENT (ONE COURSE: 5-FU 250 MG/BODY/24 HR FOR 1 WEEK ON AND 1 WEEK OFF) WAS CONDUCTED. TUMOR MARKER LEVELS DECREASED AND DIAGNOSTIC IMAGING SHOWED PROGRESSIVE REMISSION. HOWEVER THE CATHETER BECAME OCCLUDED DURING THE 14TH COURSE OF HEPATIC ARTERIAL INFUSION, RESULTING IN THE RE-ELEVATION OF TUMOR MARKER LEVELS. WHEN THE FIRIS REGIMEN (ONE COURSE: S-1 80 MG/M2 FOR 2 WEEKS ON AND 2 WEEKS OFF AND IRINOTECAN: CPT-11 125 MG/M2 ON DAYS 1 AND 15) WAS ADMINISTERED, TUMOR MARKERS FELL TO A LEVEL LOWER THAN THAT PREVIOUSLY ACHIEVED WITH HEPATIC ARTERIAL INFUSION. SEE ATTACHED LITERATURE ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention