MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number	TFH-9000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	06/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Other contributing factors for skin erosion in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information), concomitant dexamethasone (impaired wound healing is listed as a side effect.Source: dexamethasone prescribing information), underlying cancer disease, prior radiation and prior surgery affecting skin integrity.Skin erosion leading to vp shunt revision was not reported in the ef-11 pivotal trial in recurrent glioblastoma or in the commercial program to date.The optune instructions for use cautions that use of the device with implanted medical devices in the brain may lead to tissue damage.Scalp necrosis is a known complication of vp shunt placement.Vp shunt complications have been reported in the literature as occurring in 11.8% of patients with brain tumors, with 6.7% of patients requiring shunt removal (source: nigim et al, oncology, 2015, 3:1381-1386).
Event or Problem Description
Patient with recurrent glioblastoma on bevacizumab plus nivolumab began optune therapy on (b)(6) 2016.On (b)(6) 2016, patient developed a skin reaction (described as "sores") and temporarily discontinued optune therapy.Patient was not hospitalized or medically treated for the event.On (b)(6) 2016, the patient resumed optune therapy.On july 7, 2015, novocure was informed by the prescribing site nurse that the patient had experienced skin erosion near the area of her ventriculoperitoneal (vp) shunt (inserted on (b)(6) 2015).Optune therapy was discontinued.Vp shunt was removed on (b)(6) 2016.Wound and blood cultures were negative.Patient was seen at the prescriber's clinic on (b)(6) 2016 and the surgical site was healing.Prescriber assessed the event as related to optune therapy.

• Brand Name: OPTUNE
• Common Device Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• MDR Report Key: 5808355
• Report Number: 3009453079-2016-00074
• Device Sequence Number: 16300084
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/20/2016

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
• Operator of Device: 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: 15 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FUROSEMIDE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 86