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 01/09/2024

Event Type  Injury  

Event Description

A 63-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2023.Novocure was informed on january 09, 2024, that on an unknown date the patient required additional surgery due to a wound healing disorder at the surgical resection site that existed since the previous unspecified surgery (last surgical resection (b)(6) 2023).Reportedly, a new implant was inserted to replace the skull plate.Optune gio therapy was temporarily discontinued.The prescribing physician did not provide a causality assessment.

Manufacturer Narrative

Novocure 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, underlying cancer disease, 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 from the treating physician on (b)(6) 2024, that following a tumor recurrence and two surgical procedures, one for recurrence and another for a wound healing disorder and radiation, the patient had a small wound that required additional surgery on an unspecified date.The physician advised the discontinuation of 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: 18658180
• MDR Text Key: 334732985
• Report Number: 3010457505-2024-00256
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107981194
• UDI-Public: (01)07290107981194(11)210727
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/12/2024

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?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2021
• 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: CANDESARTAN; LEVETIRACETAM; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female