BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 12071570 · Received June 25, 2021

    Report

    Report Number
    3008769756-2021-00054
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    November 23, 2020
    Report Date
    May 27, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 NEUWAVE DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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 · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: EVALUATION OF MEDIUM-TERM EFFICACY OF Y90 RADIATION SEGMENTECTOMY VS PERCUTANEOUS MICROWAVE ABLATION IN PATIENTS WITH SOLITARY SURGICALLY UNRESECTABLE <4 CM HEPATOCELLULAR CARCINOMA: A PROPENSITY SCORE MATCHED STUDY AUTHOR/S: LINZI ARNDT, ALEXANDER VILLALOBOS, WILLIAM WAGSTAFF, BERNARD CHENG, MINZHI XING, ROBERT M. ERMENTROUT, ZACHARY BERCU, MIRCEA CRISTESCU, ANAND SHAH, JOEL WEDD, BILL S. MAJDALANY, JOSEPH F. MAGLIOCCA, MARTY T. SELLERS, NIMA KOKABI CITATION: CARDIOVASC INTERVENT RADIOL HTTPS://DOI.ORG/10.1007/S00270-020-02712-1 THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF Y90 RADIATION SEGMENTECTOMY (RS) VS. PERCUTANEOUS MICROWAVE ABLATION (MWA) IN PATIENTS WITH SOLITARY HCC <4 CM. FROM MARCH 2014 TO MARCH 2017, 68 PATIENTS (N=34 TREATED WITH MWA; N=34 TREATED WITH Y90 RS) WHO WERE DIAGNOSED WITH SOLITARY HEPATOCELLULAR CARCINOMA (HCC) UP TO 4 CM WITHOUT PREVIOUS LIVER-DIRECTED INTERVENTIONS WERE INCLUDED IN THIS STUDY. FOR PATIENTS UNDERGOING MWA, ALL ABLATIONS WERE PERFORMED USING GENERAL ANESTHESIA AS AN OUTPATIENT PROCEDURE. MWA PROBE PLACEMENT WAS PERFORMED UNDER COMPUTED TOMOGRAPHY (CT) GUIDANCE WITH OR WITHOUT ADDITION OF ULTRASOUND AT THE DISCRETION OF THE OPERATOR. NUMBER OF PROBES USED WAS BASED ON CLINICIAN DISCRETION AND DEPENDING ON THE LOCATION AND THE SIZE OF THE LESION. ABLATION TIME AND GENERATOR POWER WERE DETERMINED USING MANUFACTURER GUIDELINES (NEUWAVETM, ETHICON, SOMERVILLE, NJ, USA). ALL PATIENTS UNDERWENT MULTIPHASIC CONTRAST ENHANCED CT IMMEDIATELY AFTER MWA TO ENSURE ABSENCE RESIDUAL VIABLE TUMOR. IF THERE WAS RESIDUAL TUMOR, FURTHER ABLATION WAS PERFORMED IN THE SAME SETTING. FOR PATIENTS UNDERGOING RS, RS WAS PERFORMED VIA A SUPER SELECTIVE TECHNIQUE USING Y90 GLASS-BASED MICROSPHERES (THERASPHERE,BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA). THE DOSIMETRY PLANNING WAS CONDUCTED ACCORDING TO MANUFACTURER¿S PACKAGE INSERT WITH 120 GY DOSE PLANNED FOR THE CORRESPONDING LOBE, AND THE PRESCRIBED ACTIVITY ADMINISTERED TO THE TARGETED SEGMENT AFTER LOCATION WAS CONFIRMED VIA ANGIOGRAPHY. ALL Y90 RS WERE PERFORMED AS AN OUTPATIENT. PROCEDURE RELATED TOXICITY WAS ASSESSED AT APPROXIMATELY 3¿6 MONTHS POST THERAPY AND GRADED ACCORDING TO CLINICAL COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS, (CTCAE) VERSION 5. ADVERSE EVENTS WERE MEASURED CLINICALLY AT 3 MONTHS (NINE POINTS) AND VIA LAB VALUES AT 3¿6 MONTHS (EIGHT POINTS) POST-TREATMENT USING THE CTCAE GRADING SYSTEM. CLINICAL CTCAE WERE ASSESSED AT 3-MONTH FOLLOWUP WHILE LABORATORY CTCAE WAS COLLECTED BETWEEN 3¿6 MONTHS AFTER TREATMENT. THE MEAN AGE FOR THE STUDY POPULATION WAS 63.0 Y (67 Y ± 17 (SD) IN THE MWA GROUP AND 61 Y ± 11 (SD) IN THE RS GROUP) (P = 0.491). REPORTED COMPLICATIONS IN THE MWA GROUP INCLUDED GRADE 1 ASCITES (N=22), GRADE 2 ASCITES (N=8), GRADE 4 ASCITES (N=1), GRADE 1 FATIGUE (N=1), GRADE 2 FATIGUE (N=1), GRADE 1 ABDOMINAL PAIN (N=1), GRADE 2 ABDOMINAL PAIN (N=1), GRADE 2 VOMITING (N=1) AND GRADE 1 ANOREXIA (N=1). IN CONCLUSION, OUR DATA SUGGEST Y90 RS ACHIEVES SIMILAR TUMOR RESPONSE AND OS WITH A SIMILAR SAFETY COMPARED TO MWA IN THE MANAGEMENT OF HCC LESIONS B 4 CM. ADDITIONALLY, TARGETED TUMOR PFS APPEARS TO BE PROLONGED IN THE RS GROUP WITH SIMILAR NON-TARGET LIVER PFS BETWEEN RS AND MWA GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962602 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1