MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: concomitant 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 Description

A 57-year-old male with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.On (b)(6) 2024, novocure was informed by the patient´s healthcare provider (hcp), that on (b)(6) 2023, the patient developed a wound dehiscence in the area of the surgical resection scar, which was located below one of the adhesive electrodes causing him discomfort.Per provided outpatient letter, the wound dehiscence was noted as small and dry and required a single suture along with wound cleaning on (b)(6) 2024.In addition, antibiotic therapy (clindamycin) was initiated.Optune gio therapy was discontinued as of (b)(6) 2023.The hcp noted that the patient could resume optune gio therapy once the wound dehiscence had healed, and the suture removed.On (b)(6) 2024, novocure was informed that the patient was unable to resume optune gio therapy as the patient had a non-healing wound on the surgical resection scar that repeatedly became ulcerated.The prescribing physician did not provide a causality assessment on this event.

• 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: 19200244
• MDR Text Key: 341241757
• Report Number: 3010457505-2024-00273
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 7290107981194
• UDI-Public: (01)7290107981194(11)180307
• 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
• Type of Report: Initial
• Report Date: 04/29/2024

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 Model Number: TFH9100
• Device Catalogue Number: TFH9100EU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2018
• 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; LEVETIRACETAM; PANTOPRAZOLE; PARACETAMOL; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male