MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 06/04/2023

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the contribution of arrays 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 was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only.

Event Description

A 42-year old female patient with astrocytoma, who grade iv, started optune therapy on (b)(6) 2023.On (b)(6) 2023, novocure was informed by the patient that the she had experienced a wound healing disorder that had not improved and was referred to wound management service.The treating physician recommended to temporarily discontinue optune therapy (therapy interrupted as of (b)(6) 2023).It was noted that the wound worsened due to the array adhesive.On (b)(6) 2023, the patient reported she was hospitalized.On (b)(6), 2023, prescribing physician reported that the patient had a prior episode of wound healing disorder with a post-operative staphylococcus aureus infection with left frontal wound revision on (b)(6) 2022 (last surgical resection (b)(6), 2022).The physician noted the patient had lowered optune use since treatment start due to wound issues.On (b)(6) 2023, the patient was hospitalized and underwent wound revision on (b)(6) 2023, due to wound dehiscence (0.7x0.8 cm) on the left frontal surgical resection scar.Intraoperatively, there was no evidence of infection.Postoperatively the wound was dry without irritation with mild swelling in the left temple region.The patient was discharged in stable condition on (b)(6) 2023.Optune therapy was planned to be resumed in (b)(6) 2023 depending on wound condition.The physician did not provide a causality assessment.

Manufacturer Narrative

Novocure received additional information on july 5, 2023, that the wound on the patient´s surgical resection scar had opened.The spouse noted the wound healing disorder was unresolved and a follow up appointment with the healthcare provider was planned for (b)(6) 2023.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• 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: 17245044
• MDR Text Key: 318264432
• Report Number: 3010457505-2023-00240
• Device Sequence Number: 1
• Product Code: NZK
• 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,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• 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
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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: TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female