BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIDENT

    MDR report key: 8244814 · Received January 14, 2019

    Report

    Report Number
    1717344-2019-00078
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    September 3, 2012
    Report Date
    January 14, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    PMA / PMN Number
    K011676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: "RECURRENCE AFTER MICROWAVE ABLATION OF LIVER MALIGNANCIES: A SINGLE INSTITUTION EXPERIENCE" SOURCE: HPB, (365¿371), 2013. ARTICLE NUMBER: 15. DATE OF PUBLICATION: 03 SEPT 2012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE, THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EXAMINE A MONOCENTRIC EXPERIENCE WITH MICROWAVE ABLATION (MWA), WITH A PRIMARY HYPOTHESIS THAT PRIMARY TUMOUR HISTOLOGY WAS A SIGNIFICANT PREDICTOR OF EARLY RECURRENCE. SEVENTY-TWO PATIENTS (43 FEMALE, 60%) UNDERWENT 83 MWA PROCEDURES FOR 157 TUMOURS. EVIDENT¿ MWA SURGICAL ANTENNAE, EVIDENT¿ MWA PUMP TUBING AND CHAMBERS, VALLEYLAB¿ MW ABLATION GENERATORS AND VALLEYLAB¿ MW ABLATION PUMPS WERE USED FOR ALL PROCEDURES (COVIDIEN¿, FORMERLY VALLEYLAB¿; BOULDER, CO, USA), WITH THE GENERATOR SET TO 45 WATTS. MORBIDITY WAS REPORTED AT 16% (13/83 TOTAL PROCEDURES) AND WHILE 5 COMPLICATIONS WERE GRADE III OR HIGHER PER THE CLAVIEN-DINDO SYSTEM, THE SPECIFIC COMPLICATIONS WERE NOT REPORTED. 90-DAY MORTALITY WAS 1%, FOR 1 PATIENT WHO DIED FROM ¿RAPID PROGRESSION¿ OF METASTATIC CARCINOID HISTOLOGY, 52 DAYS AFTER UNCOMPLICATED MWA WITH HEMIHEPATECTOMY. BY THE END OF FOLLOW-UP (MEDIAN 16 MONTHS) 31% (21/72) PATIENTS HAD DIED, THOUGH THIS WAS DESCRIBED IN CONTEXT OF OVERALL SURVIVAL FROM THE DISEASE AND NOT ATTRIBUTED TO THE PROCEDURE. ARTICLE: "RECURRENCE AFTER MICROWAVE ABLATION OF LIVER MALIGNANCIES: A SINGLE INSTITUTION EXPERIENCE." AUTHOR: T. CLARK GAMBLIN. YEAR: 2013. INTERNATIONAL HEPATO-PANCREATO-BILIARY ASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36821 EVIDENT SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER VTGEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention