BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 12144544 · Received July 9, 2021

    Report

    Report Number
    3008769756-2021-00069
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    November 26, 2020
    Report Date
    June 10, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SURGICAL MICROWAVE ABLATION OF OTHERWISE NON-RESECTABLE COLORECTAL CANCER LIVER METASTASES: EXPANDING OPPORTUNITIES FOR LONG TERM SURVIVAL AUTHOR: KENDALL R. MCEACHRON, JACOB S. ANKENY, ALEXANDRIA ROBBINS, ARIELLA M. ALTMAN, SCHELOMO MARMOR, DONNA D¿SOUZA , ROBBEN SCHAT, BENJAMIN SPILSETH, ERIC H. JENSEN CITATION: HTTPS://DOI.ORG/10.1016/J.SURONC.2020.11.016. THIS STUDY AIMED TO REVIEW INSTITUTIONAL EXPERIENCE WITH SURGICAL THERMAL ABLATION OF COLORECTAL LIVER METASTASES (CRLM) DEEMED SURGICALLY UNRESECTABLE. A TOTAL OF 36 PATIENTS WITH 135 LESIONS ABLATED OVER 40 SURGICAL PROCEDURES FROM 2009 TO 2018 WERE INCLUDED. ALL PATIENTS INCLUDED IN THE STUDY WERE TREATED BY ONE SURGICAL ONCOLOGIST (EHJ) USING A CERTUS 140 2.45 GHZ ABLATION SYSTEM, CERTUS PR XT 20 CM, OR LK MAX XT 25 CM PROBES (NEUWAVE MEDICAL, MADISON, WI, USA) DEPENDING ON THE SIZE AND LOCATION OF THE TARGET TUMOR. ALL PROCEDURES WERE PERFORMED IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA. AFTER CONFIRMING THE ABSENCE OF ANY EXTRAHEPATIC METASTASES, ADDITIONAL PORTS WERE PLACED TO FACILITATE INTRAOPERATIVE ULTRASOUND, THE MICROWAVE ABLATION PROBES AND ADDITIONAL TROCARS AS NEEDED FOR RETRACTION OR DISSECTION. LAPAROSCOPIC ULTRASOUND WAS USED IN ORDER TO EVALUATE THE LIVER AND IDENTIFY TARGET LESIONS. ONCE THE LESIONS WERE IDENTIFIED, MICROWAVE ABLATION WAS PERFORMED USING ONE OR TWO PROBES UNDER ULTRASOUND GUIDANCE TO TARGET THE LESION AND CONFIRM ADEQUATE TISSUE MICRO-BUBBLING. GENERALLY, FOR LESIONS 1.5 CM OR LESS, A SINGLE ABLATION PROBE WAS USED (MAXIMUM ABLATION DIAMETER OF 3.5 CM). FOR LESIONS 1.5¿2.5 CM, LESIONS WERE TARGETED WITH TWO PROBES (MAXIMUM ABLATION DIAMETER OF 4.5 CM). LESIONS 2.5¿3 CM WERE TARGETED WITH THREE PROBES (MAXIMUM ABLATION DIAMETER 5.1 CM). ALL TREATMENTS WERE PLANNED SO THAT THE ABLATION SIZE WOULD BE 2 CM LARGER THAN THE TUMOR DIAMETER. ALL ABLATIONS WERE PERFORMED UNDER ULTRASOUND VISUALIZATION AND REPOSITIONING OF THE NEEDLES WITH REPEAT BURNS WERE PERFORMED IF THERE WAS CONCERN FOR INADEQUATE ABLATION BASED ON THE EXTENT OF MICROBUBBLING. MEDIAN NUMBER OF ABLATED LESIONS PER PATIENT WAS 2 (RANGE 1¿15). MEDIAN MAXIMUM DIAMETER OF ABLATED LESIONS WAS 1.9 CM (RANGE 0.5¿12.2). MEDIAN FOLLOW UP OF THE STUDY WAS 28 MONTHS. REPORTED COMPLICATIONS INCLUDED RE-ADMISSIONS FOR POST-OP PAIN MANAGEMENT AT 30-DAY POSTOP (N=3), TUMOR LYSIS SYNDROME AT 30-DAY POSTOP (N=1) AND ABLATION SITE RECURRENCE AT 28TH MONTH FOLLOW-UP (N=6) . IN CONCLUSION, SURGICAL ABLATION OF CRLM CAN PROVIDE EXCELLENT LOCAL CONTROL AND LONG-TERM SURVIVAL OUTCOMES IN PATIENTS WHO MAY OTHERWISE NOT BE CANDIDATES FOR OTHER LIVER-DIRECTED THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040454 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1