MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problems Seizures (2063); Thrombosis (2100)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

Novocure concurs with prescribing physician that the events were not related to optune therapy.Seizures were reported as adverse events on the pivotal phase iii 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 (anaplastic oligoastrocytoma).Thrombosis (listed as pulmonary embolism in the ifu) was reported on the pivotal ef-11 recurrent gbm trial as an adverse event in both arms of trial (1% optune therapy and 2% chemotherapy arm; related 0% optune therapy, 1% chemotherapy).Hypercoagulability and risk for venous thromboembolism in the setting of a cancer diagnosis and chemotherapy administration has been described extensively (e.G.Nccn guidelines 2015 - venous thromboembolic disease).In addition, multiple studies in the literature describe the incidence of pulmonary embolism in gbm patient population from 0.5 - 8%.Risk factors for thrombosis in this patient include: underlying cancer disease, previous chemotherapy treatment, and concomitant bevacizumab (a vegf inhibitor noted to increase the risk of thrombotic events - per bevacizumab prescribing information).

Event Description

Patient with recurrent anaplastic oligoastrocytoma began optune therapy on (b)(6) 2015.Following a scheduled mri on (b)(6) 2015, patient was admitted to the hospital due to elevated blood pressure.Optune was discontinued upon admission.Further testing revealed thromboses and patient underwent an unspecified procedure to "prevent clots from traveling to the lungs." patient had no history of thromboembolic disease.Following the procedure, patient experienced three seizures (no further information provided), but otherwise remained stable.Patient did not have a history of seizure and was not on anti-seizure medication.Patient was discharged on (b)(6) 2015 with home hospice care and planned to restart optune therapy.Per prescribing physician, the events were not related to optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): 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, 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5130286
• MDR Text Key: 27577682
• Report Number: 3009453079-2015-00059
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• 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: consumer
• Reporter Occupation: Other
• Report Date: 09/25/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2013
• 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: LISINOPRIL
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 76