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 Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	03/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure agrees with the prescribing physician that the events were related to concomitant bevacizumab.Other contributing factors for wound infection and wound dehiscence 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 and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), underlying cancer disease, prior radiation and prior surgery affecting skin integrity.Wound infection and wound dehiscence were not reported as adverse events in the ef-11 recurrent gbm pivotal trial.In the commercial program, wound infection has been reported by <1% of patients and wound dehiscence has been reported by <1% of patients to date.
Event or Problem Description
Patient with recurrent glioblastoma began optune therapy on (b)(6) 2016.On (b)(6) 2016 the patient reported to their prescriber that they were experiencing pain and erythema at the craniotomy incision site (resection performed on (b)(6) 2016).Prescriber noted the left cranial incision had a quarter inch opening with minimal erythema.There was no active drainage.Optune therapy was temporarily discontinued.On (b)(6) 2016 the patient underwent wound debridement, removal of infected bone flap, and subgaleal fluid collection drain placed.Surgical culture was positive for (b)(6).The patient was discharged home on (b)(6) 2016 on intravenous cefazolin (2 g every 8 hours).At a postoperative follow-up appointment on (b)(6) 2016, the patient denied tenderness, drainage, erythema or warmth with the wound.Sutures were removed and incision was well approximated with the exception of a small area above the craniectomy defect.There was no evidence of erythema, infection or drainage.There was no opening at the site.Prescriber advised patient to restart optune therapy, avoiding the area of the scalp incision.The prescribing physician stated that the event was related to concomitant bevacizumab.

• 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: 5695589
• Report Number: 3009453079-2016-00073
• Device Sequence Number: 171637
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 4 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2016
• Initial Report FDA Received Date: 06/02/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Weight: 79