MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure 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 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 or Problem Description
A 65 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2022.On (b)(6) 2022, novocure was informed the patient experienced a sore on the scalp with exposed cranial hardware.Optune therapy was temporarily discontinued.On (b)(6) 2023, the spouse reported the patient underwent a craniotomy on that day, no further information was provided.On (b)(6) 2023, the prescribing physician reported the patient was not hospitalized.Physical examination on an unspecified date, showed a small sub centimeter area of skin dehiscence at the incision site of her prior craniotomy (last surgical resection (b)(6) 2021), which was a very thin portion of skin approximately 3 mm with exposed hardware (surgical plate).The physician sent the patient to neurosurgery to be evaluated.Optune therapy was temporarily interrupted per physician advice.The physician was not aware of the recommendations of neurosurgery, thus cannot provide further details.On (b)(6)3, it was reported the patient underwent surgery approximately two weeks prior and suture removal planned for the following week.A causality assessment to the event was not provided.

• Brand Name: OPTUNE
• Common Device Name: 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: 16237314
• Report Number: 3010457505-2023-00225
• Device Sequence Number: 17740081
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BEVACIZUMAB; CHOLECALCIFEROL; DEXAMETHASONE; ELTROMBOPAG; ERGOCALCIFEROL; FLUCONAZOLE; LEVETIRACETAM; LORATADINE; ONDANSETRON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG