BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 21916357 · Received April 28, 2025

    Report

    Report Number
    3010457505-2025-00488
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 28, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107986328
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE WOUND DEHISCENCE CANNOT BE RULED OUT. WOUND DEHISCENCE IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND <1% EF-14 OPTUNE ARM). CONTRIBUTING FACTORS FOR WOUND DEHISCENCE IN THIS PATIENT INCLUDE CONCOMITANT BEVACIZUMAB (VEGF INHIBITOR WHICH CARRIES A BLACK BOX WARNING FOR WOUND HEALING COMPLICATIONS, SOURCE BEVACIZUMAB PRESCRIBING INFORMATION), UNDERLYING CANCER DISEASE AND PRIOR SURGERY AFFECTING SKIN INTEGRITY.

    Description of Event or Problem · 0

    A 73-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO ON (B)(6) 2024. ON APRIL 2, 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT HAD DEVELOPED MULTIPLE PAINFUL AND ITCHY LESIONS ON THE SCALP BENEATH THE OPTUNE GIO TRANSDUCER ARRAYS. THE PATIENT'S ONCOLOGIST ADVISED TEMPORARILY DISCONTINUING OPTUNE GIO THERAPY TO ALLOW THE LESIONS TO HEAL. AN IMAGE WAS PROVIDED THAT REVEALED A WOUND DEHISCENCE AT THE SITE OF THE LEFT TEMPORAL SURGICAL RESECTION SCAR (LAST SURGICAL RESECTION ON (B)(6) 2024) AND MODERATELY REDDENED, CRUSTED LESIONS ON THE TOP AND BACK OF THE HEAD. AS A RESULT, OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON APRIL 14, 2025, THE PRESCRIBING PHYSICIAN CONFIRMED THAT THE EVENT WAS RELATED TO OPTUNE GIO THERAPY AND FURTHER AGGRAVATED BY THE USE OF BEVACIZUMAB. THE USE OF STEROIDS WAS NOTED AS AN ADDITIONAL RISK FACTOR. BOTH OPTUNE GIO THERAPY AND BEVACIZUMAB TREATMENT WERE SUSPENDED UNTIL THE LESIONS WERE RESOLVED. ON APRIL 16, 2025, NOVOCURE RECEIVED UPDATED INFORMATION INDICATING THAT THE PATIENT HAD RESUMED OPTUNE GIO THERAPY ON (B)(6) 2025, FOLLOWING THE HEALING OF THE INITIAL IRRITATION. HOWEVER, THE PATIENT EXPERIENCED RECURRING SKIN REACTIONS, CONSULTED HER ONCOLOGIST, AND THE THERAPY WAS AGAIN TEMPORARILY DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237329 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107986328

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention NOT PROVIDED.