BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 8428797 · Received March 18, 2019

    Report

    Report Number
    3008769756-2019-00022
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 21, 2019
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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. PLEASE CONFIRM THE SPECIFIC NUMBER OF PATIENTS THAT EXPERIENCED SEVERE PAIN, INTRAPARENCHYMAL BLEEDING, AND CHRONIC PULMONARY ASPERGILLOSIS. DOES THE PHYSICIAN BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: "MICROWAVE ABLATION IN THE MANAGEMENT OF COLORECTAL CANCER PULMONARY METASTASES." AUTHORS: I. KURILOVA, A. GONZALEZ-AGUIRRE, R. G. BEETS-TAN, J. ERINJERI, E. N. PETRE, M. GONEN, M. BAINS, N. E. KEMENY, S. B. SOLOMON, C. T. SOFOCLEOUS. CITATION: CARDIOVASC INTERVENT RADIOL (2018) 41: 1530¿1544; HTTPS://DOI.ORG/10.1007/S00270-018-2000-6, PUBLISHED ONLINE: 29MAY2018. THIS RETROSPECTIVE REVIEW OF DATA ASSESSED ONCOLOGIC OUTCOMES AND COMPLICATIONS OF MWA IN THE MANAGEMENT OF PATIENTS WITH COLORECTAL PULMONARY METASTASES AS WELL AS FACTORS AFFECTING THESE OUTCOMES. BETWEEN MARCH 2011 AND MAY 2016, FIFTY PATIENTS (MALE N=22, FEMALE N=28) WITH 90 COLORECTAL LUNG METASTASES WERE TREATED IN 60 MWA SESSIONS. NEUWAVE MWA SYSTEM WAS USED IN NINETY ONE PERCENT OF THE COLORECTAL LUNG METASTASES. COMPLICATIONS INCLUDED SEVERE PAIN OR INTRAPARENCHYMAL BLEEDING REQUIRING THORACOSTOMY WHICH PROLONGED PATIENT¿S HOSPITALIZATION; AND CHRONIC PULMONARY ASPERGILLOSIS IN THE ABLATION ZONE 2 MONTHS AFTER MWA WHICH REQUIRED HOSPITALIZATION FOR 2 DAYS WITH PROLONGED TREATMENT WITH VORICONAZOLE (6 WEEKS 200MGP/OS EVERY 12HOURS AND SUBSEQUENT 6 WEEKS OF 10 ¿ 400 MG IVPB EVERY 12 HOURS). IN CONCLUSION, MWA WITH MINIMAL ABLATION MARGIN = 5MM IS ESSENTIAL FOR LOCAL CONTROL OF COLORECTAL CANCER PULMONARY METASTASES. PLEURAL-BASED METASTASES AND LARGER TUMOR SIZE WERE ASSOCIATED WITH HIGHER RISK OF LTP. CEA LEVEL AND PRE-MWA CHEMOTHERAPY IMPACTED CSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223456 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYSTEM - NWA1US1N