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 12/11/2023

Event Type  Injury  

Event Description

A 70-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6)2020.Novocure was informed on (b)(6)2023, that surgery was planned on an unspecified date to remove cranial hardware (screw) on the patient´s scalp.The patient remained on optune gio therapy, placing the transducer arrays to avoid the affected area.In an available medical record, the prescribing physician noted on (b)(6)2023, the patient had multiple small abrasions and superficial flat eschars on the scalp.The optune transducer arrays were placed securely around the eschars.The patient was scheduled for a left craniotomy revision on (b)(6) 2024, due to a skin erosion on the scalp with exposed cranial hardware.There were no signs of infection or bleeding and the patient denied fever, pain or headache.Optune gio therapy has been temporarily discontinued.The prescribing physician did not provide a causality assessment on this event.

Manufacturer Narrative

Novocure medical opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: prior radiation, prior chemotherapy 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).

Manufacturer Narrative

Novocure received additional information on january 31, 2024, that the patient had surgery to remove the cranial hardware (screw), although additional surgery would be needed including a skin graft to close the incision in the future.The neurosurgeon advised discontinuing optune gio therapy.

• 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: 18593852
• MDR Text Key: 333895510
• Report Number: 3010457505-2024-00255
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: TFH9100US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2017
• 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: ATORVASTATIN; LEVETIRACETAM; LEVOTHYROXINE; LISINOPRIL; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female