MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/21/2024

Event Type  Injury  

Event Description

A 58-year-old male patient with newly diagnosed glioblastoma started optune gio therapy on (b)(6) 2023.On (b)(6) 2024, novocure received the information, that the patient had a wound complication at the craniotomy site, which required surgical wound revision.On (b)(6) 2024, the patient reportedly experienced three weeks of discomfort in the area of the bone flap and recurring neck pain.Patient underwent cranial mri on (b)(6) 2024, which showed local tumor progression.During an outpatient appointment with neurosurgery on (b)(6) 2024, regarding the discussion of a recurrence surgery, the patient reported recurring putrid secretion from the surgical resection scar (last surgical resection (b)(6) 2023) since (b)(6) 2023, which was treated with antibiotics at the time, but the putrid secretion persisted.During the visit, the patient's craniotomy wound appeared without irritation, however with little putrid secretion.Due to the local infection, the treating physician recommended wound revision surgery for exclusion of bone flap infection with suspicion of a fistula prior to recurrence resection.Optune gio therapy was discontinued as of (b)(6) 2024.On (b)(6) 2024, the patient was hospitalized and underwent wound revision surgery and fistula removal without any complications.An intraoperative culture confirmed staphylococcus aureus and intravenous antibiotic therapy (flucloxacillin) was started post-operatively.On (b)(6) 2024, the patient underwent an additional wound revision surgery with removal of the bone flap.The post-operative course was unremarkable and antibiotic treatment was discontinued upon patient´s discharge from the hospital on (b)(6) 2024.The prescribing physician stated that a connection between the wound infection after osteoplastic trepanation and optune gio therapy is uncertain.

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the wound infection cannot be ruled out.Contributing factors for wound infection in this patient include: prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation and underlying cancer disease and prior wound complications.Wound infection is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).

• Brand Name: OPTUNE GIO
• Type of Device: 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; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 19009949
• MDR Text Key: 338980155
• Report Number: 3010457505-2024-00268
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107981194
• UDI-Public: (01)07290107981194(11)200707
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DEXAMETHASONE.; NEBIVOLOL.; PANTOPRAZOLE.; TEMOZOLOMIDE.; TORASEMIDE.; VALSARTAN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG