MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problem Seizures (2063)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is 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).Death is an expected event in patients with recurrent gbm due to the natural history of the disease.On the pivotal phase iii trial overall survival was 6.3/6.4 months in the optune therapy and chemotherapy arms respectively.

Event Description

Patient with recurrent glioblastoma (gbm) began optune therapy on (b)(6) 2015 as part of the investigator sponsored trial "proposed pilot study of combined novottf-100a, bevacizumab, and hypo-fractionated stereotactic irradiation for bevacizumab-naive, recurrent glioblastoma".On (b)(6) 2015, novocure was informed that the patient had been hospitalized due to grade 3 seizures.Patient discontinued optune therapy upon admission.Patient had a history of seizures and was on anti-seizure medication (levetiracetam) at the time of the event.Patient planned to transition to (b)(6) due to disease progression.Per prescribing site research coordinator, the seizure was probably related to underlying disease and possibly related to optune therapy.On (b)(6) 2015 novocure was informed that the patient had died on (b)(6) 2015.Prescribing physician stated the cause of death was underlying glioblastoma and was unrelated to optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5222671
• MDR Text Key: 31179292
• Report Number: 3009453079-2015-00065
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: 18 MO
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 68 YR
• Patient Weight: 74