MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Wound Dehiscence (1154); Ulcer (2274)

Event Date 10/04/2021

Event Type  Injury  

Event Description

A female patient, of an unknown age, with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.On an unspecified date, the spouse noticed minor wounds had developed on the patient's scalp.On (b)(6) 2021, optune therapy was temporarily discontinued.On (b)(6) 2021, during an oncology consult, it was noted that three necrotic pressure ulcers were visible on the scalp.One measuring approximately 1.5-2 cm was located at the left posterior of the scalp with visible cranial hardware and osteosynthesis material.The second ulcer was elongated and measured approximately 1.5 cm with exposed osteosynthesis material.The third ulcer on the right frontal area appeared slightly smaller also with exposure of osteosynthesis material.No infection noted.The patient was instructed to avoid the ulcers when placing the transducer arrays on the scalp.The prescriber planned to consult with neurosurgery for surgical removal of osteosynthetic material.On (b)(6) 2021, the patient resumed optune therapy.On (b)(6) 2021, during a neurological office visit the scalp ulcers were graded as severe (3-4).On (b)(6) 2021, per the spouse, optune therapy was discontinued on (b)(6) 2021, due to skin irritation.Per prescribing physician, the patient had developed necrotic wounds due to the combination of bevacizumab, immunosuppressants, localized group iii steroids, osteosynthetic material and anxiety.The physician assessed the event as related to optune therapy due to the patient's reluctance to discontinue therapy despite the complications.

Manufacturer Narrative

Novocure's medical opinion is that a contribution of the arrays to wound dehiscence and medical device site ulcer cannot be ruled out.Contributing factors for wound dehiscence and medical device site ulcer in this patient include: underlying cancer disease, prior surgery affecting skin integrity, bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), and immunosuppression.Medical device site ulcer 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 the optune arm of the trial (<1%).Wound dehiscence was reported in the ef-14 trial the optune/tmz arm of the trial (<1%) only.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• MDR Report Key: 12720637
• MDR Text Key: 282350836
• Report Number: 3009453079-2021-00187
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/29/2021

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: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BETAMETHASONE VALERATE; BEVACIZUMAB; MICONAZOLE/HYDROCORTISONE; OXYCODONE/NALOXONE; PARACETAMOL
• Patient Outcome(s): Hospitalization