MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Ulcer (2274); Post Traumatic Wound Infection (2447)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that a contribution of the array placement to medical device site ulcer cannot be ruled out.Contributing factors for an ulcer and wound infection 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.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 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).

Event Description

A (b)(6) male with newly diagnosed glioblastoma started optune therapy on (b)(6) 2020.In (b)(6) 2021, the spouse reported that she noticed a wound on the right side of the patient's scalp near the surgical resection site (latest surgical resection (b)(6) 2020).A topical ointment (petrolatum/mineral oil) had been used to treat the wound with no improvement.On (b)(6) 2021, patient was seen in the wound clinic due to non-healing wounds.Upon examination, two ulcers were observed at full thickness however, slough obscured wound beds preventing actual wound depth determination.Erythema, induration, and inflammation were not present.The ulcer on the top part of the scalp measured 1.1 x 0.8 cm, the perimeter was pink, and wound bed was moist with moderate serosanguineous drainage.The ulcer on the right part of scalp measured 0.4 x 0.6 cm, the perimeter was dry, and wound bed was moist with serosanguineous drainage.Patient was instructed to treat the wounds with a prescribed topical wound medication (100% active leptospermum manuka honey), and apply a small circular dressing daily.On (b)(6) 2021, patient presented to the emergency department (ed) due to nonhealing wounds on the scalp.Ed physician examined the patient's scalp and noted two wounds measuring at 1 cm in diameter with visible cranium hardware.Patient was started on antibiotics (cefalexin 500 mg) with instructions to follow up with neurosurgery and remain off optune therapy until examined.On (b)(6) 2021, during the follow up visit, neurosurgery assessed that the right lateral scalp wound measured 10 to 15 mm in diameter, with complete exposure of the cranium hardware with surrounding erythema and granulation.No drainage could be expressed.Wound revision surgery was consented, however, the patient wanted to discuss with his family before proceeding.On (b)(6) 2021, prescribing site nurse reported that the patient would remain off optune therapy due to skin issues.Per prescribing physician, the event was related to optune therapy.

Manufacturer Narrative

On june 25, 2021, novocure received additional information.The spouse reported that on (b)(6) 2021, the patient underwent surgery that reportedly required 62 staples to close the incision.Appointment to remove the staples was planned for on (b)(6) 2021.

Manufacturer Narrative

On september 24, 2021, novocure discovered the unique identifier (udi) number was incorrectly entered for both previous reports in section b4.Correct submission date for mdr 3009453079-2021-00175 f1 should be july 13, 2021.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• MDR Report Key: 12053375
• MDR Text Key: 268049392
• Report Number: 3009453079-2021-00175
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 00729017982021
• UDI-Public: 0729017982021
• 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,Followup,Followup
• Report Date: 10/19/2021

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: 06/02/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/25/2021; 09/24/2021
• Supplement Dates FDA Received: 07/13/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APIXABAN; BEVACIZUMAB; DEXAMETHASONE; DRONABINOL; MENTHOL-ZINC OXIDE; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 90