BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 15130580 · Received July 29, 2022

    Report

    Report Number
    2134265-2022-07693
    Event Type
    Injury
    Date Received
    July 29, 2022
    Date of Event
    May 5, 2011
    Report Date
    July 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MYUNGSU LEE, KOREAN J RADIOL 2021;22(10):1658-1670. PROSPECTIVE MULTI-CENTER KOREAN REGISTRY OF TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION WITH DRUG-ELUTING EMBOLICS FOR NODULAR HEPATOCELLULAR CARCINOMA: A TWO-YEAR OUTCOME ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT IN A STUDY TO ACCESS THE TWO-YEAR TREATMENT OUTCOMES OF CHEMOEMBOLIZATION WITH DRUG-ELUTING EMBOLICS (DEE) FOR NODULAR HEPATOCELLULAR CARCINOMA (HCC), 11 OF 152 PATIENTS EXPERIENCED SERIOUS ADVERSE EVENTS. THIS STUDY WAS A PROSPECTIVE MULTICENTER REGISTRY BASED SINGLE-ARM CLINICAL TRIAL PERFORMED AT FIVE UNIVERSITY HOSPITALS IN KOREA. THE TARGET PATIENT POPULATION WAS 200 (48 WERE EXCLUDED FROM THE ANALYSIS ON CENTRAL REVIEW AS THEY DID NOT MEET ALL THE INCLUSION CRITERIA), AND PATIENTS WERE RECRUITED FROM MAY 2011 TO APRIL 2013. A VIAL OF DC BEADS WITH 70-75 MG OF DOXORUBICIN WAS USED FOR TREATMENT. FOR A STANDARD PROCEDURE, EMBOLICS OF 100-300 UM IN SIZE WERE RECOMMENDED. HOWEVER, THE CHOICES OF THE ACTUAL AMOUNT OF DOXORUBICIN AND EMBOLIC SIZE WERE DETERMINED BY OPERATORS CONSIDERING SPECIFIC PATIENT AND TUMOR CHARACTERISTICS. A SUPER SELECTIVE (SEGMENTAL OR SUB SEGMENTAL) APPROACH WAS USED WHENEVER POSSIBLE BY USING A SMALL-BORE MICROCATHETER (2.0 TO 2.4 FRENCH). THE RECOMMENDED EMBOLIZATION ENDPOINT WAS NEAR STASIS (THE CONTRAST COLUMN WAS CLEAR WITHIN 2-5 HEARTBEATS ON THE COMPLETION ANGIOGRAPHY). A TREATMENT CYCLE CONSISTED OF DIFFERENT NUMBERS OF TREATMENT SESSIONS THAT REQUIRED TO COVER ALL THE VIABLE TUMORS. UP TO TWO VIALS OF DEE WERE ALLOWED FOR EACH SESSION. IN PATIENTS WITH A LARGE TUMOR BURDEN IN WHOM TWO VIALS OF DEE WERE INSUFFICIENT, A SEPARATE SPLIT SESSION WAS RECOMMENDED AT A TWO- TO FOUR-WEEK INTERVAL TO COMPLETE THE CYCLE. REGULAR CLINICAL FOLLOW-UP WAS PERFORMED USING LABORATORY AND IMAGING STUDIES. TUMOR RESPONSE ASSESSMENT WAS PERFORMED WITH DYNAMIC CONTRAST-ENHANCED CT OR MRI AT ONE, THREE, AND SIX MONTHS AFTER THE PROCEDURE AND AT THREE-MONTH INTERVALS THEREAFTER. TO INVESTIGATE THE EFFICIENCY OF INDIVIDUAL TARGET TUMORS, A DETAILED PER-LESION TUMOR RESPONSE ASSESSMENT WAS PERFORMED. IN SUMMARY, DEE CHEMOEMBOLIZATION FOR NODULAR HCCS IN THE KOREAN POPULATION SEEMS EFFECTIVE AND SAFE EVEN AFTER A TWO-YEAR FOLLOW-UP. SERIOUS ADVERSE EVENTS WERE REPORTED IN 11 PATIENTS (7.2%). THE CAUSES WERE POST-EMBOLIZATION SYNDROME (PES) IN FIVE PATIENTS, BILIARY INJURY IN FOUR, A NECESSITY FOR ADMISSION TO CONTROL ASCITES IN ONE, AND CEREBRAL INFARCTION NOT RELATED TO DISEASE OR TREATMENT IN ONE. THE PROMINENT BILIARY INJURY WAS DEMONSTRATED ON IMAGING IN 30 PATIENTS (19.7%). NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094908 DC BEAD KRD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization