MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure's medical opinion is that a contribution of the array placement to the wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include; dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 66-year-old female patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.During review of an available medical record, it was reported on (b)(6) 2024, the patient experienced persistent wounds on the scalp in relation to optune gio usage and from previous surgery.The physician advised rotating the transducer arrays, avoiding the affected areas, and applying topical clobetasol cream and clindamycin gel.Novocure was informed on (b)(6) 2024, that when the patient removed the transducer arrays a few days prior, the skin on the scalp was very thin and cranial hardware (metal plate) had become exposed.Optune gio therapy was temporarily discontinued.On (b)(6) 2024, the patient met with a neurosurgeon that advised additional surgery might be needed to remove the cranial hardware.The spouse mentioned that potentially, optune gio therapy would be discontinued.The prescribing physician was contacted for further details without reply.
Additional Manufacturer Narrative
During review of a medical record received by novocure on july 30, 2024, it was confirmed during an oncology follow up visit on (b)(6) 2024, the patient had surgery for the removal of exposed cranial hardware on (b)(6) 2024.Reportedly there were no complications and the patient recovered well.The patient was prescribed cephalexin and topical mupirocin ointment for antibiotic prophylaxis.Optune gio therapy was temporarily discontinued since (b)(6) 2024.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmoouth, NH 03801 ; 2077527602
• MDR Report Key: 19621591
• Report Number: 3010457505-2024-00289
• Device Sequence Number: 20863546
• Product Code: NZK
• UDI-Device Identifier: 07290107982214
• UDI-Public: (01)07290107982214(11)160410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEXAMETHASONE; LEVETIRACETAM; LEVOTHYROXINE; ONDANSETRON; TEMOZOLOMIDE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG