BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 20698735 · Received November 15, 2024

    Report

    Report Number
    3008769756-2024-00036
    Event Type
    Death
    Date Received
    November 15, 2024
    Date of Event
    November 17, 2023
    Report Date
    November 15, 2024
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 11/15/2023 B3: PUBLICATION YEAR OF 2024 D4: BATCH # UNK D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THERE ANY DEVICE DEFICIENCIES DURING THE ORIGINAL PROCEDURES? DOES THE AUTHOR/SURGEON BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS AND/OR PATIENT DEATH MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IS THE AUTHOR/SURGEON INTERESTED IN SPEAKING WITH NEUWAVE/ETHICON MEDICAL ABOUT THIS SITUATION? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: SURGICAL MICROWAVE ABLATION FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMA IN 791 OPERATIONS. AUTHORS: ANSLEY B. RICKER1, ERIN H. BAKER1, MATTHEW S. STRAND1, ALEKSANDR KALABIN1, VINCENT BUTANO1, ALEXANDRA WELLS1, MICHAEL PHILLIPS1, HUAPING WANG2, IAIN MCKILLOP1, GIULIANA IANNITTI1, JOEL CASINGAL1, JOHN B. MARTINIE1, DIONISIOS VROCHIDES1 & DAVID A. IANNITTI1 CITATION: HPB; HTTPS://DOI.ORG/10.1016/J.HPB.2023.11.009 THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE OUTCOMES OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) UNDERGOING SURGICAL MICROWAVE ABLATION (MWA). BETWEEN MARCH 2007 AND DECEMBER 2022, A TOTAL OF 791 OPERATIONS IN 623 PATIENTS (MEDIAN AGE OF 64 YEARS) AND 1156 HCC TUMORS WERE TREATED WITH SURGICAL MWA. MULTIPLE ABLATION SYSTEMS WERE USED AT OUR INSTITUTION OVER THE COURSE OF THIS STUDY WHICH INCLUDE 915 MHZ (COVIDIEN, EVIDENTÒ) AND 2.45 GHZ (MEDTRONIC, EMPRINTÔ, EMPRINTÔ SX, EMPRINTÔ HP, MICROSULIS, ACCULISÒ, ANGIODYNAMICS, SOLEROÒ, JOHNSON & JOHNSON NEUWAVE CERTUSÒ) SYSTEMS WITH OR WITHOUT IMAGE GUIDANCE. THE SELECTION OF THE MWA SYSTEM EMPLOYED WAS AT THE DISCRETION OF THE SURGEON; HOWEVER, IT SHOULD BE NOTED THAT THERE WAS A MIGRATION AWAY FROM USING 915 MHZ SYSTEMS WITH THE EMERGENCE OF 2.45 GHZ SYSTEMS. REPORTED COMPLICATIONS INCLUDE DEATH DUE TO SEPSIS (N=?), RECURRENCE DUE TO INCOMPLETE ABLATION (N=?), SEPSIS (N=?), SURGICAL SITE INFECTION (N=?), AND UNKNOWN EVENT REQUIRING REOPERATION (N=?). IN CONCLUSION, SURGICAL MWA OFFERS A LOW-MORBIDITY APPROACH FOR TREATMENT OF HCC, AFFORDING LOW RATES OF INCOMPLETE ABLATION AND LOCAL RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144950 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death