MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Cognitive Changes (2551)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

It is unclear if the clinical symptoms in this patient were due to treatment effect (i.E., radionecrosis), pseudoprogression or true tumor progression.Diagnosis is difficult without a biopsy with histopathology or time.Following radiotherapy, changes on conventional mri including increased perilesional edema and worsened enhancement may represent tumor progression or response to radiation.Approximately 50% of patients will experience imaging changes connoting tumor progression within 1 month of radiation therapy of which 50% are likely to have pseudoprogression rather than progressive disease.Radionecrosis typically is reported within 3-12 months following radiation treatment, with incidence ranging from 5-40% of patients (ellingson et al., j neurooncol 134 (3): 495-504, 2017).As these events occurred approximately 4 months after the completion of this patient's radiation treatment, they fall within the reported timeframes for either pseudoprogression (3-6 months) or radiation necrosis.Clinical symptoms of acute radiation injury are signs of increased intracranial pressure with progressive focal defects which are typically transient and reversible.Steroids usually alleviate clinical signs and symptoms, as seen in this patient.Novocure opinion is that it is possible that the clinical symptoms were due to a combined treatment effect of radiation plus optune.Radiation necrosis was reported in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the tmz arm of the study only (1%).In the commercial program, there have been (b)(4) prior reports of radiation necrosis, all of which were non-serious and assessed as not related to optune therapy.

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018.On (b)(6) 2018, the patient's spouse reported that the patient had been hospitalized.Per hospital summary, the patient presented to the hospital on (b)(6) 2018 with worsening confusion, progressive headaches and gait imbalance of 3-4 days duration.Brain mri showed possible disease progression and vasogenic edema.Patient was given 10mg intravenous dexamethasone and admitted to the neuro intensive care unit for monitoring and further assessment.The tumor board concluded the cause of the event was treatment effect rather than recurrence and recommended continuation of dexamethasone plus temozolomide and optune.Patient was discharged home in improved condition on (b)(6) 2018 and started on dexamethasone 4mg bid.At the time of the report, the patient had resumed optune therapy.Per the prescriber, the cause of the events leading to admission was treatment effect, possibly a combination of radiation and optune therapy.

Manufacturer Narrative

On december 23, 2021, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4-suspect medical device model number.Corrected model number is tfh9100.

• 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; hacarmel 4th floor; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 7979755
• MDR Text Key: 124166094
• Report Number: 3009453079-2018-00108
• Device Sequence Number: 1
• Product Code: NZK
• 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,Followup
• Report Date: 01/07/2022

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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: ACETAMINOPHEN.; LORAZEPAM.; OMEPRAZOLE.; ONDANSETRON.; SENOKOT.; TEMOZOLOMIDE.; ACETAMINOPHEN; LORAZEPAM; OMEPRAZOLE; ONDANSETRON; SENOKOT; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 98 KG