MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problems Infarction, Cerebral (1771); Seizures, Focal Motor (2064); Respiratory Failure (2484)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician that the events were related to underlying gbm and were not related to optune therapy.Seizures were reported as adverse events on the pivotal phase 3 recurrent gbm trial in both arms of the trial (9% and 4% in optune therapy and chemotherapy arms respectively).None of these seizures were considered device or chemotherapy related by investigators.Seizures are a known complication of the underlying disease (recurrent gbm).Ischemic stroke was not reported as an adverse event in the ef-11 pivotal trial.There have been 8 prior reports in the commercial program, which were assessed as not related to optune.Respiratory failure was not reported as an adverse event in the ef-11 pivotal trial.There have been 2 prior reports in the commercial program, which were assessed as not related to optune.Additional risk factors in this patient include: concomitant bevacizumab (carries a warning for serious, sometimes fatal, arterial thromboembolic events including cerebral infarction.Source: bevacizumab prescribing information), prior cigarette smoking (40 plus packs a year), age, prior radiotherapy, prior tumor resection surgery, and obstructive sleep apnea.

Event Description

Patient with recurrent glioblastoma began optune therapy on (b)(6) 2015.On (b)(6) 2015 the patient presented to the emergency room with right sided face, hand, and leg weakness and difficulty expressing words.With some movement of the right hand.Shortly after arrival, the patient experienced a focal seizure and had difficulty expressing words and was unable to maintain respiration.The patient was intubated and admitted to intensive care with ventilator support and intravenous fluids.Patient had experienced 1 prior seizure in 2002 but had no seizures since gbm diagnosis ((b)(6) 2014).Patient was on topiramate 100 mg twice daily for seizure control at time of hospitalization and was subsequently started on valproate 500 mg twice daily while in-patient.Ct scan showed questionable brainstem infarct and patient was started on low-dose aspirin for stroke prevention.Eeg was abnormal due to presence of slow waves ranging 4-6hz, possibly representing encephalopathy.Mri showed central and cortical atrophy, and changes of chronic periventricular ischemia, and an area of abnormal diffusion restriction involving the left posterior corpus callosum and adjacent to the left lateral horn.Patient was also treated for hyponatremia.Laboratory tests were normal however sodium was significantly high at 146.Ct head scan showed questionable brainstem infarct with encephalomalacia in left parietal and right frontal region from the brain cancer and cancer surgery.Eeg was abnormal due to presence of slow wave.Mri showed cortical atrophy and changes of chronic periventricular ischemia.The physician started the patient on baby aspirin for stroke prevention.The patient's last seizure was in 2012 and seizure activity was maintained with anti-seizure medication (topiarate) 100 mg twice daily.The patient was given a new anti-seizure medication (valproate 500 mg twice daily) while inpatient.Patient was discharged on (b)(6) 2015 with home health care, physical and occupational therapy.Discharge medications included low-dose aspirin, potassium chloride, topiramate, amoxicillin/clauvulanate and ciprofloxacin.Per the prescribing physician, the events were related to the patient's underlying disease (recurrent gbm) and were not related to optune.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5127478
• MDR Text Key: 27455235
• Report Number: 3009453079-2015-00058
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• 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
• Reporter Occupation: Other
• Report Date: 09/22/2015

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: TFH-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• 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: BUMETANIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 98