BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 20665936 · Received November 12, 2024

    Report

    Report Number
    3008769756-2024-00028
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    March 19, 2024
    Report Date
    November 12, 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: 11/12/2024. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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: SAFETY AND EFFICACY OF PERCUTANEOUS IMAGE-GUIDED ABLATION FOR SOFT TISSUE SARCOMA METASTASES TO THE LIVER. AUTHORS: AHMED AWAD MBBS,K OUSTAV PAL MBBS, STEVEN YEVICH MD, JOSHUA D. KUBAN MD, ALDA TAM MD, BRUNO C. ODISIO MD, SANJAY GUPTA MD, PEIMAN HABIBOLLAHI MD, ANDREW J. BISHOP MD, ANTHONY PAUL CONLEY MD, NEETA SOMAIAH MD, DEJKA M. ARAUJO MD, MARIA ALEJANDRA ZARZOUR MD, RAVIN RATAN MD, CHRISTINA L. ROLAND MD, EMILY Z. KEUNG MD, STEVEN Y. HUANG MD, RAHUL A. SHETH MD CITATION: AWAD A, PAL K, YEVICH S, ET AL. SAFETY AND EFFICACY OF PERCUTANEOUS IMAGE-GUIDED ABLATION FOR SOFT TISSUE SARCOMA METASTASES TO THE LIVER. CANCER. 2024;130(15): 2703-2712. DOI:10.1002/CNCR.35330. THIS STUDY AIMS TO EVALUATE OUTCOMES FOLLOWING PERCUTANEOUS IMAGE-GUIDED ABLATION OF SOFT TISSUE SARCOMA METASTASES TO THE LIVER. BETWEEN JANUARY 2011 AND DECEMBER 2021, A TOTAL OF 55 PATIENTS (23 MALE AND 32 FEMALE) WITH A MEAN AGE OF 67 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD HISTOPATHOLOGICAL DIAGNOSIS OF METASTATIC SOFT TISSUE SARCOMA (STS) WHO UNDERWENT PERCUTANEOUS LIVER ABLATION WITH ETHANOL + MICROWAVE ABLATION, RADIOFREQUENCY ABLATION, IRREVERSIBLE ELECTROPORATION, AND MICROWAVE ABLATION. REPORTED COMPLICATIONS INCLUDE (N=1) ABSCESS FORMATION AND INFECTION, AND (N=1) PNEUMOTHORAX THAT WAS AND SUCCESSFULLY REMOVED THE FOLLOWING DAY. CONCLUSION: THIS STUDY FOUND THAT PLA IS AN EFFECTIVE APPROACH FOR ACHIEVING LOCAL TUMOR CONTROL IN PATIENTS WITH METASTATIC STS, EVIDENCED BY THE HIGH RATES OF LOCAL TUMOR PFS AND OS COMBINED WITH A LOW COMPLICATION PROFILE. NOTABLY, THE HISTOLOGY-AGNOSTIC ABLATION EFFICACY IS UNDERSCORED BY COMPARABLE LOCAL TUMOR PFS BETWEEN LEIOMYOSARCOMA AND GIST, INDICATING THAT IMAGE-GUIDED ABLATION CAN YIELD EQUALLY FAVORABLE RESULTS ACROSS THE DIVERSE STS LANDSCAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540023 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention