BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOZENE MICROSPHERES

    MDR report key: 15126290 · Received July 28, 2022

    Report

    Report Number
    2134265-2022-07857
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    March 7, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL UNIVERSITY. SZEMITKO, MARCIN, ET AL. "EVALUATION OF CRC-METASTATIC HEPATIC LESION CHEMOEMBOLIZATION WITH IRINOTECAN-LOADED MICROSPHERES, ACCORDING TO THE SITE OF EMBOLIZATION." JOURNAL OF PERSONALIZED MEDICINE 12.3 (2022): 414.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. ABSTRACT WITH THE CHEMEMBOLIZATION OF COLORECTAL-CANCER (CRC)-METASTATIC HEPATIC LESIONS BY IRINOTECAN-LOADED MICROSPHERES, MOST RESEARCHERS RECOMMEND SLOW EMBOLIZATE DELIVERY AT THE LOBAR-ARTERY LEVEL TO THE ENTIRE LIVER PARENCHYMA WITHOUT OBTAINING VISIBLE STASIS. AN ASSOCIATION HAS BEEN REPORTED BETWEEN POSTOPERATIVELY VISIBLE EMBOLIZATE STASIS AND LESION RESPONSE TO TREATMENT. POSSIBLY, IN SOME CASES, MORE SELECTIVE ADMINISTRATION MIGHT GIVE GREATER BENEFIT, PARTICULARLY WITH PREVIOUS SYSTEMIC CHEMOTHERAPY FAILURE. OBJECTIVE: TREATMENT RESPONSE EVALUATION AFTER CHEMOEMBOLIZATION OF CRC-METASTATIC LIVER LESIONS WITH IRINOTECAN-LOADED MICROSPHERES, ACCORDING TO A HEPATIC-ARTERY BRANCH LEVEL OF ADMINISTRATION. PATIENTS AND METHODS: THE ANALYSIS INCLUDED 54 PATIENTS (24 FEMALES, 30 MALES) WITH LARGE (MEDIAN DIAMETER > 5 CM) CRC-METASTATIC LIVER LESIONS, WHO UNDERWENT 196 CHEMOEMBOLIZATION PROCEDURES (MEAN 3.63 PER PATIENT) WITH IRINOTECAN (100 MG)-LOADED MICROSPHERES. PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO INITIAL EMBOLIZATE-ADMINISTRATION BRANCH LEVEL: GROUP A (N = 26): AT THE SEGMENTAL OR SUBSEGMENTAL-VESSEL LEVEL; GROUP B (N = 28): AT THE LOBAR-BRANCH LEVEL. TREATMENT RESPONSE WAS ASSESSED BY COMPUTED-TOMOGRAPHY (MRECIST CRITERIA); OVERALL SURVIVAL (OS) AND PROGRESSION-FREE SURVIVAL (PFS) WERE CALCULATED USING THE KAPLAN - MEIER METHOD AND ADVERSE EFFECTS WERE ASSESSED ACCORDING TO THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE; VERSION 5.0). RESULTS: THERE WERE STATISTICALLY SIGNIFICANT DIFFERENCES IN THE OCCURRENCE OF PARTIAL RESPONSE (PR): HIGHER IN GROUP A (42.3%) THAN GROUP B (17.9%) (P = 0.039) AND OCCURRENCE OF STABLE DISEASE (SD): LOWER (P = 0.025) IN GROUP A (11.5%) THAN GROUP B (39.4%). HOWEVER, OCCURRENCE OF DISEASE PROGRESSION (PD) WAS SIMILAR: GROUP A: 42.3%; GROUP B: 42.9% (P = 0.93). PATIENTS IN GROUP A PRESENTED WITH MORE FAVORABLE PFS (P = 0.029) AND OS (P = 0.039) THAN GROUP B. MEDIAN SURVIVAL TIMES: GROUP A: 15.2 MONTHS; GROUP B: 13.1 MONTHS. THERE WAS NO SIGNIFICANT DIFFERENCE IN COMPLICATION INCIDENCE BETWEEN GROUPS (GROUP A: SEVEN COMPLICATIONS; GROUP B: SIX COMPLICATIONS; P = 0.863). THERE WERE A TOTAL OF 13 (6.6%) SIGNIFICANT COMPLICATIONS IN THE CHEMOEMBOLIZATIONS PERFORMED: 7 IN GROUP A AND 6 IN GROUP B (NOT SIGNIFICANTLY DIFFERENT; P = 0.863). IN TWO PATIENTS (ONE IN GROUP A AND ONE IN GROUP B), AN ANAPHYLACTIC REACTION OCCURRED DURING THE PROCEDURE, WHICH WAS RESOLVED AFTER AN INTERVENTION BY THE ANESTHESIA TEAM. ONE PATIENT IN GROUP A EXPERIENCED A SEPTIC EPISODE WITH A LIVER ABSCESS TWO WEEKS AFTER THE LAST PROCEDURE, SUCCESSFULLY TREATED WITH ANTIBIOTIC THERAPY. THREE PATIENTS (INCLUDING ONE FROM GROUP A) SHOWED ULTRASOUND SIGNS OF CHOLECYSTITIS, WHICH WAS RESOLVED AFTER CONSERVATIVE TREATMENT. TWO PATIENTS IN GROUP A HAD CONCOMITANT OCCLUSION OF THE RIGHT AND LEFT BRANCH OF THE HEPATIC ARTERY. IN ANOTHER TWO PATIENTS (INCLUDING ONE FROM GROUP A), SIGNS OF DECOMPENSATED LIVER DISEASE WERE FOUND WITH ASCITES. IN THREE PATIENTS (INCLUDING ONE FROM GROUP A), LEUKOPENIA (WHITE BLOOD CELL COUNT < 2000 /MM3) WAS FOUND 14 DAYS AFTER THE PROCEDURE. THERE WERE NO DEATHS IN THE PERIOPERATIVE PERIOD OR WITHIN 30 DAYS AFTER SURGERY. CONCLUSION: SUPERSELECTIVE CHEMOEMBOLIZATE ADMINISTRATION TO VESSELS SUPPLYING LARGE CRC-METASTATIC LIVER LESIONS GAVE BETTER RESPONSE TO TREATMENT AND EXTENDED PATIENT SURVIVAL TIME, WITHOUT SIGNIFICANTLY INCREASING COMPLICATION RISK. ASSESSMENT OF COMPLICATIONS: COMPLICATIONS WERE ASSESSED ON THE BASIS OF OBSERVATIONS OF THE PATIENT DURING HOSPITALIZATION AND AT FOLLOW-UP EXAMINATIONS AT SEVEN AND 21 DAYS AFTER THE PROCEDURE. ADVERSE EFFECTS AND COMPLICATIONS OCCURRING PERIOPERATIVELY AND WITHIN 30 DAYS OF THE PROCEDURE WERE ASSESSED ACCORDING TO THE STANDARDS AND TERMINOLOGY OF THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE; VERSION 5.0). DATA WERE SAVED IN A FORM SUITABLE FOR STATISTICAL EVALUATION (EXCEL 2007; MICROSOFT, WASHINGTON, DC, USA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656040 ONCOZENE MICROSPHERES DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention