BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_PUMP

    MDR report key: 3833108 · Received May 27, 2014

    Report

    Report Number
    3007566237-2014-01435
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    January 27, 2013
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4). ACTUAL EVENT DATE WAS UNKNOWN. THIS DATE IS BASED ON THE DATE OF PUBLICATION (DAY AND MONTH UNKNOWN). WAS NOT POSSIBLE TO MATCH THIS EVENT TO A PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    SUBBIAH, I.M., SUBBIAH, V., TSIMBERIDOU, A.M., NAING, A., KASEB, A.O., JAVLE, M., FU,S., HONG,D.S., PIHA-PAUL, S., WHELER, J.J., HESS, K.R., JANKU, F., FALCHOOK, G.S., WOLFF, R.A., KURZROCK, R. TARGETED THERAPY OF ADVANCED GALLBLADDER CANCER AND CHOLANGIOCARCINOMA WITH AGGRESSIVE BIOLOGY: ELICITING EARLY RESPONSE SIGNALS FROM PHASE 1 TRIALS. ONCOTARGET. 2013;4(1):153-162. SUMMARY: PATIENTS WITH ADVANCED CHOLANGIOCARCINOMA (CC) AND GALLBLADDER CARCINOMA (GC) HAVE FEW THERAPEUTIC OPTIONS FOR RELAPSED DISEASE. GIVEN THE OVERALL POOR PROGNOSIS IN THIS POPULATION AND THE AVAILABILITY OF NOVEL TARGETED THERAPIES, WE SYSTEMATICALLY ANALYZED THE CHARACTERISTICS AND OUTCOMES FOR GC AND CC PATIENTS TREATED ON PHASE I TRIALS WITH AN EMPHASIS ON TARGETED AGENTS AND LOCOREGIONAL THERAPIES. OF 40 TREATED PATIENTS (GC=6; CC=34; MEDIAN AGE, 60 YEARS), 8 (20%) HAD STABLE DISEASE (SD) > 6 MONTHS, 3 (8%) PARTIAL RESPONSE (PR), ON PROTOCOLS WITH HEPATIC ARTERIAL DRUG INFUSION AND ANTI-ANGIOGENIC, ANTI-HER-2/NEU OR NOVEL MAPK/ ERK KINASE (MEK) INHIBITORS. MEDIAN PROGRESSION-FREE SURVIVAL (PFS) ON PHASE I TRIALS WAS 2.0 MONTHS (95% CI 1.7, 2.8) VERSUS 3.0 MONTHS (95% CI 2.4, 5.0), 3.0 MONTHS (95% CI 2.3, 4.6), AND 3.0 MONTHS (95% CI 2.4, 3.9) FOR THEIR FIRST-, SECOND-, AND LAST-LINE FDA-APPROVED THERAPY. IN UNIVARIATE ANALYSIS, >3 METASTATIC SITES, ELEVATED ALANINE AMINOTRANSFERASE (ALT) (>56IU/L), SERUM CREATININE (>1.6MG/DL), AND CA19-9 (>35U/ML) WERE ASSOCIATED WITH A SHORTER PFS. MUTATIONAL ANALYSIS REVEALED MUTATION IN THE KRAS ONCOGENE IN 2 OF 11 PATIENTS (18%). THE SD >6 MONTHS/PR RATE OF 28% WAS SEEN WITH HEPATIC ARTERIAL INFUSION OF OXALIPLATIN, AND INHIBITORS OF ANGIOGENESIS, HER-2/NEU OR MEK. THE PFS IN PHASE I TRIALS WAS SIMILAR TO THAT OF THE FIRST, SECOND, AND LAST-LINE THERAPY (P=0.95, 0.98, 0.76, RESPECTIVELY) WITH FDA-APPROVED AGENTS GIVEN IN THE ADVANCED SETTING, EMPHASIZING A ROLE FOR TARGETED AGENTS IN A CLINICAL TRIALS SETTING AS POTENTIALLY VALUABLE THERAPEUTIC OPTIONS FOR THESE PATIENTS. REPORTED EVENT: DEVELOPMENT OF AN ARTERIOVENOUS FISTULA IN ONE PATIENT DUE TO THE PLACEMENT OF THE HEPATIC ARTERIAL INFUSION CATHETER WAS A GRADE 3 TOXICITY THAT PROMPTED REMOVAL FROM THE STUDY. MASTER FILE, NO RELATED FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311098 UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other