BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIDENT

    MDR report key: 8332035 · Received February 12, 2019

    Report

    Report Number
    1717344-2019-00192
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    May 15, 2018
    Report Date
    February 12, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    UDI-DI
    10884524001579
    PMA / PMN Number
    K011676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE NEW MICROWAVE ABLATION SYSTEM FOR UNRESECTABLE LIVER TUMORS THAT FORMS LARGE, SPHERICAL ABLATION ZONES SOURCE JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, VOLUME 33, 2018 (2007¿2014) DATE OF PUBLICATION: 15 MAY 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED MARCH 2017 AND DECEMBER 2017, THERE WERE NO DEATHS OF ANY OF PATIENTS WHO UNDERWENT MWA. HOWEVER, ONE PATIENT EXPERIENCED AN ADRENAL GLAND-INDUCED TAKOTSUBO (STRESS) CARDIOMYOPATHY IMMEDIATELY AFTER MWA. ADDITIONALLY, ONE SUBDIAPHRAGMATIC HCC NODULE ABLATION WAS COMPLICATED BY A PLEURAL EFFUSION, AND ABLATION OF A HCC NODULE NEAR THE BILE DUCT WAS COMPLICATED BY A BILOMA, DIAGNOSED BY CT AFTER THE ABLATION. THESE COMPLICATIONS WERE RESOLVED BY CONSERVATIVE MEDICAL TREATMENT. REGARDING THE TAKOTSUBO CARDIOMYOPATHY, AUTHORS STATE THAT ¿IT WAS ASSOCIATED WITH MICROWAVE ABLATION WAS NOTED IN (B)(6) YEAR-OLD PATIENT WITH HCC LOCATED IN LIVER LOBE S7 RECEIVED MWA ABLATION. THE DIAMETER OF THE TUMOR WAS 45.1 MM IN THE LONG-AXIS DIAMETER41.1 MM IN THE SHORT-AXIS DIAMETER, AND 40.2 MM IN THE VERTICAL AXIS DIAMETER. THE MWA ANTENNA WAS INSERTED PERCUTANEOUSLY BY AN EXPERT IN LOCAL HCC TREATMENT. THE PATIENT HAD SEVERE HYPERTENSION (SYSTOLIC BLOOD PRESSURE/DIASTOLIC BLOOD PRESSURE, 264/133 MMHG) DURING THE MWA (APPROXIMATELY 9 MIN ABLATED BY 100 W) FOLLOWING VENTRICULAR TACHYCARDIA DESPITE DISCONTINUATION OF THE ABLATION. CARDIAC CATHETERIZATION WAS PERFORMED IMMEDIATELY, AND THE ISSUE WAS DIAGNOSED AS TAKOTSUBO CARDIOMYOPATHY. THE PATIENT RECOVERED UNDER CONSERVATIVE MEDICAL TREATMENT AFTER APPROXIMATELY 1 WEEK FOLLOWING THE MWA. THE POST-PROCEDURE CT SCAN SHOWED THE RESIDUAL HCC AND THE ABLATED RIGHT ADRENAL GLAND DESPITE A NONDIRECT PUNCTURE. THE AUTHORS FURTHER NOTE IN THE DISCUSSION SECTION THAT THE ¿TAKOTSUBO CARDIOMYOPATHY OBSERVED IN ONE PATIENT WAS PROBABLY INDUCED BY EXCESSIVE CATECHOLAMINES DERIVED FROM THE ABLATED ADRENAL GLAND. THEREFORE, THE MWA ACTIVE ZONE MUST BE PLACED AT LEAST 1 CM FROM SURROUNDING ORGANS SUCH AS THE ADRENAL GLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126210 EVIDENT SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER VTGEN 10884524001579

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other