MAUDE Adverse Event Report: NOVOCURE LTD OPTUNE

Model Number TFH-9000

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

Patient Problem Death (1802)

Event Date 12/04/2014

Event Type  Death  

Event Description

Pt with recurrent gliosarcoma began optune therapy on (b)(6) 2014.At the time of treatment start, pt was residing in a rehabilitation facility following an ischemic stroke.The following day, optune therapy was discontinued (reason not provided).Approx 1 hour later, pt became unresponsive and was brought to the er.Code blue was called immediately due to pt status.Pt was very, unresponsive and 100% non-rebreather mask was applied.Sternal rub was performed and pt was aroused.Iv access was obtained, ekg performed (results not provided).Physical exam was unremarkable.Pt was prepped for transfer to another hospital upon wife's request but the pt again became unresponsive with no pulse.Second code blue was called.Cpr was initiated, lucas chest compression system was applied and pt was intubated.Two doses of epinephrine were administered.Final diagnosis in hospital summary included unresponsiveness, shortness of breath and diaphoresis, but no cause of death was provided.No adverse event associated with device use were reported.The time of last optune use was not known until the equipment was returned to novocure and the logfiles downloaded on 01/02/2015.Per logfile review, last device use was (b)(6) 2014 at 14:43 and device was functioning as per normal operating parameters.

Manufacturer Narrative

Novocure medical opinion is that the death was not related to optune.Pt was not on optune therapy when he became unresponsive.Additionally, pt was at a high risk for a thromboembolic event due to recent stroke with associated cerebral edema and heavy pretreatment with bevacizumab (a vegf inhibitor noted to increase the risk of thrombotic events - per bevacizumab prescribing information).Death is an expected event in patients with recurrent gliosarcoma due to the natural history of the disease.Overall survival ranges from 4/18.5 months [huo et al., int j clin exp pathol 2014; 7 (9) : 6323-6332].

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD; haifa 0000 ; IS 0000
• Manufacturer Contact: eilon kirson ; topaz bldg. sha'ar hacarmel; 4th fl; haifa 00003-1905 ; IS 000031905 ; 48501204
• MDR Report Key: 4468493
• MDR Text Key: 5184671
• Report Number: 3009453079-2015-00048
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/02/2015

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
• Other Device ID Number: 07290107980401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2015
• Initial Date FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Weight: 108