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 06/27/2023

Event Type  Injury  

Event Description

A 56-year old female patient with recurrent glioblastoma (gbm) started optune therapy on (b)(6) 2022, as part of the investigator sponsored trial ´´ enhancing tumor treating fields therapy for recurrent glioblastoma with targeted and individualized skull remodeling surgery.A multi-center, randomized phase ii trial´´.Novocure was informed on (b)(6) 2023, that the patient had a wound on the surgical resection scar.Optune therapy was temporarily discontinued.On (b)(6) 2023, the patient reported that she experienced a persistent wound on the surgical resection scar (last surgical resection (b)(6) 2022) that advanced to the cranial hardware (skull plate).On an unknown date, she underwent surgery due to an infection.On july 17, 2023, novocure received a serious adverse event report (sae) that noted two weeks prior to the event the patient had developed a skin rash and blisters around the wound.Optune therapy was temporarily discontinued and a cortisol cream was applied on the affected area with an initial positive response.After resuming optune therapy a wound dehiscence was identified.On an unknown date, the wound was evaluated in an outpatient clinic and an infection could not be excluded.Thus, wound revision surgery was scheduled for (b)(6) 2023.No infection signs were detected during the surgery, although the bone flap was removed out of caution.Patient was discharged on (b)(6) 2023, with potential plans of implantation of a titanium plate, however due to patient's skin being extremely thin, might not be possible.The investigators believed the cause of the wound dehiscence was a combination of optune therapy, bevacizumab treatment, steroid use, and tobacco smoking.

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: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source bevacizumab prescribing information), prior 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 has not been reported in the pivotal ef-11 recurrent gbm trial.There have been 172 reports of wound dehiscence in the commercial program to date.

• 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: 17422333
• MDR Text Key: 320019556
• Report Number: 3010457505-2023-00243
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2018
• 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: BEVACIZUMAB.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female