MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Solid Tumour (4552)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that nodular fasciitis was related to the underlying disease (gbm) and unrelated to optune therapy.Nodular fasciitis was not reported as an adverse event in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm.There have been no reports of nodular fasciitis in the commercial program to date.

Event Description

A (b)(6)-year-old female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.During a scheduled brain mri on (b)(6) 2021, a new enhancing nodule was discovered in the left orbit, measuring 1.6 x 1.5 x 1.3 cm.(b)(6) 2021, positron emission tomography (pet) scan with high standardized uptake value (suv) was not convincing of a neoplastic lesion or malignancy.On (b)(6) 2021, patient underwent surgical resection to remove most of the ocular lesion.Intra-operative pathology favored a reactive benign fibroblastic and inflammatory process.Repeat brain mri on (b)(6) 2021, demonstrated a slightly smaller orbital mass and patient was started on a steroid medication taper (prednisone).On (b)(6) 2021, final pathology results confirmed myofibroblastic proliferative lesions consistent with proliferative fasciitis without evidence of malignancy.Mri performed on (b)(6) 2021, showed no significant mass effect.Left orbital infiltrative enhancement along superior left orbit superior rectus muscle was less visible compared to previous imaging.On (b)(6) 2021, novocure received information from the prescribing physician that orbital inflammation was observed during imaging.Biopsy of lesion pathology results confirmed inflammatory disease.Patient was treated with a prednisone taper and the inflammatory mass resolved.On (b)(6) 2021, prescribing physician provided additional details stating a second lesion appeared in a new location and pathology results were pending.Optune therapy was discontinued.Per prescriber, event was possibly related to optune therapy.

• 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: 13142892
• MDR Text Key: 285750628
• Report Number: 3010457505-2022-00195
• 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: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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: CLOBETASOL; LEVETIRACETAM; ONDANSETRON; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 45 KG