BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 12053291 · Received June 23, 2021

    Report

    Report Number
    3008769756-2021-00021
    Event Type
    Death
    Date Received
    June 23, 2021
    Date of Event
    January 1, 2020
    Report Date
    May 25, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 6/23/2021. EVENT DATE: ONLY EVENT YEAR KNOWN: 2020; CAPTURED AS CITATION DATE. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: THERMAL ABLATION VERSUS STEREOTACTIC BODY RADIOTHERAPY FOLLOWING TRANSARTERIAL CHEMOEMBOLIZATION FOR INOPERABLE HEPATOCELLULAR CARCINOMA: A PROPENSITY SCORE WEIGHTED ANALYSIS AUTHORS: NIMA NABAVIZADEH, MD, YOUNES JAHANGIRI, MD, RAMTIN RAHMANI, BA, YUKI TOMOZAWA, MD, PHD, YINDEE GEERATIKUN, MD, YIYI CHEN, PHD, ARTHUR HUNG, MD, CATHERINE DEGNIN, PHD, KHASHAYAR FARSAD, MD, PHD CITATION: AJR (2020), DOI:10.2214/AJR.20.24117. THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE OUTCOMES FOR INOPERABLE HCC BETWEEN TACE WITH PERCUTANEOUS THERMAL ABLATION (T-TA) AND TACE WITH STEREOTACTIC BODY RADIOTHERAPY (T-SBRT) USING PROPENSITY-SCORE-WEIGHTED COHORTS. BETWEEN 2007 TO 2018, A TOTAL OF 190 PATIENTS WITH A SINGLE INOPERABLE HCC WERE TREATED WITH EITHER T-SBRT IN 90 PATIENTS (74 MALE AND 16 FEMALE; MEDIAN AGE = 60 YEARS) OR T-TA IN 100 PATIENTS (68 MALE AND 32 FEMALE; MEDIAN AGE = 61 YEARS) AFTER PRIOR TACE. IN THE T-TA GROUP, ABLATION WAS PERFORMED USING MICROWAVE (NEUWAVE MEDICAL, ETHICON). THE MEDIAN FOLLOW-UP TIME WAS 48.2 MONTHS. REPORTED COMPLICATIONS INCLUDED DEATH (N=?), AND TREATMENT-RELATED HEPATOTOXICITY (N=9%). IN CONCLUSION, OUR ANALYSES SHOW THAT COMPARED TO T-SBRT, T-TA IS ASSOCIATED WITH IMPROVED OS AND PFS AFTER PROPENSITY-SCORE WEIGHTING. HEPATOTOXICITY WAS WORSE IN THE T-SBRT GROUP, POSSIBLY EXPLAINING THE INFERIOR OS DESPITE SIMILAR LOCAL CONTROL. HOWEVER, SUBSET ANALYSES OF THE PATIENTS WITH THE EARLIEST-STAGE HCC AND MOST PRESERVED LIVER FUNCTION IDENTIFIED SIMILAR OS AND PFS. PROSPECTIVE RANDOMIZED STUDIES EVALUATING THESE TWO COMBINED MODALITY STRATEGIES ARE WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945232 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death