BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 12016469 · Received June 17, 2021

    Report

    Report Number
    3004962788-2021-00058
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    November 4, 2020
    Report Date
    June 17, 2021
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMBINATION THERAPY BY TRANSARTERIAL INJECTION OF MIRIPLATIN-IODIZED OIL SUSPENSION WITH RADIOFREQUENCY ABLATION (RFA) VERSUS MICROWAVE ABLATION (MWA) FOR SMALL HEPATOCELLULAR CARCINOMA: A COMPARISON OF THERAPEUTIC EFFICACY. SOURCE: JAPANESE JOURNAL OF RADIOLOGY (2021) 39:376¿386 PUBLISHED ONLINE: 4 NOVEMBER 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE THERAPEUTIC EFFICACY AND COMPLICATION RATES OF MIRIPLATIN-IODIZED OIL SUSPENSION COMBINED WITH RADIOFREQUENCY ABLATION OR MICROWAVE ABLATION IN THE TREATMENT OF SMALL HEPATOCELLULAR CARCINOMAS BETWEEN JANUARY 2016 AND DECEMBER 2019. THE EMPRINT MICROWAVE ABLATION GROUP INCLUDED 68 HCC¿S IN 49 PATIENTS. COMPLICATIONS INCLUDED TWO CASES OF INTRAPERITONEAL HEMORRHAGE WHICH WERE CONTROLLED WITH TRANSCATHETER ARTERIAL EMBOLIZATION. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THESE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914101 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other