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 01/04/2023

Event Type  Injury  

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 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
• 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: 16237314
• MDR Text Key: 308065912
• Report Number: 3010457505-2023-00225
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2020
• 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; CHOLECALCIFEROL; DEXAMETHASONE; ELTROMBOPAG; ERGOCALCIFEROL; FLUCONAZOLE; LEVETIRACETAM; LORATADINE; ONDANSETRON
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG