MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/01/2023

Event Type  Injury  

Event Description

A 33-year old male patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.On (b)(6) 2023, when placing the transducer arrays, a novocure device support specialist (dss) observed purulent discharge on the patient's surgical resection scar (last surgical resection (b)(6) 2022).The patient was advised to be evaluated by a physician.On (b)(6) 2023, the patient was hospitalized as an emergency and underwent surgery that night due to a wound infection.Optune therapy was temporarily discontinued.The patient was discharged home on (b)(6) 2023, with planned suture removal on (b)(6) 2023.On (b)(6) 2023, the patient provided two images confirming the sutures were removed.The patient was instructed to remain off optune therapy until (b)(6) 2023.On (b)(6) 2023, novocure became aware that the patient had not resumed optune therapy to allow the surgery scar to heal.On (b)(6) 2023, the patient´s spouse informed novocure there was new purulent accumulation on the surgical scar.The patient was advised to seek medical attention.The prescribing physician did not provide additional information or causality assessment.

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to 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, prior chemotherapy, underlying cancer disease, and prior surgery affecting skin integrity.Wound infection is an expected event with device use and 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 both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).

Manufacturer Narrative

Novocure received additional information on march 09, 2023, that the physician recommended pausing optune therapy until (b)(6) 2023.In the image provided the surgical resection scar appears to be healing well.Patient resumed optune therapy on (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, INC.; 195 commerce way; park 6/platz 10; portsmouth NH 03801
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 16459647
• MDR Text Key: 310421994
• Report Number: 3010457505-2023-00227
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2015
• 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; TEMOZOLOMIDE
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Male