MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE; OPTUE

Model Number TFH-9100

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that although the prescriber assessed this event as not related to optune, a contribution of array placement to the wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient also include dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, chemotherapy, and prior surgery affecting skin integrity.There were no reports of wound dehiscence in the pivotal ef- 11 recurrent gbm trial.In the commercial program, wound dehiscence has been reported by <1% of patients to date.

Event Description

A (b)(6) female patient with recurrent glioblastoma began optune therapy on (b)(6) 2018.On september 03, 2018, novocure was informed by the spouse that the patient was hospitalized due to wound dehiscence at the resection scar (most recent resection (b)(6) 2018).The pictures provided by the spouse show a large area of wound dehiscence along the resection scar (according to medical record about 1.2x7 cm) with the exposed bone visible.There were no signs of wound infection.On (b)(6) 2018, it was reported to novocure that the patient underwent surgical wound revision.The prescribing physician stated that event was not related to optune therapy; she assessed the event to be due to prior radiation and long-term dexamethasone administration.Optune therapy was temporarily discontinued since (b)(6) 2018.

Event Description

On (b)(6) 2018, spouse reported that after the last wound revision a wound complication developed with purulent secretion from the resection scar.Head mri performed showed that the skull did not heal properly after the last brain surgery necessitating a bone implant.Surgery was scheduled for the following week.

Manufacturer Narrative

Novocure medical opinion is that the wound infection is not related to optune.The patient discontinued optune use on (b)(6) 2018, 53 days prior to the event.Contributing factors for wound infection in this patient include dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity.Wound infection was not reported as an adverse event in the ef-11 gbm pivotal trial.In the commercial program, wound infection has been reported by <1% of patients to date.

• Brand Name: OPTUNE
• Type of Device: OPTUE
• Manufacturer (Section D): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• MDR Report Key: 7905528
• MDR Text Key: 121583734
• Report Number: 3009453079-2018-00107
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 21 MO
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APIXABAN; CHOLECALCIFEROL; COTRIMOXAZOLE; DEXAMETHASONE; DRONABINOL; ENOXAPARIN SODIUM; ESOMEPRAZOLE; L-THYROXINE; LEVETIRACETAM; METAMIZOLE; METHADONE; MIRTAZAPINE; MOVICOL; ONDANSETRON; PYRIDOXIN HYDROCHLORIDE; TEMOZOLOMIDE; THIAMINCHLORIDE-HYDROCHLORIDE; TUMERIC; APIXABAN; CHOLECALCIFEROL; COTRIMOXAZOLE; DEXAMETHASONE; DRONABINOL; ENOXAPARIN SODIUM; ESOMEPRAZOLE; L-THYROXINE; LEVETIRACETAM; METAMIZOLE; METHADONE; MIRTAZAPINE; MOVICOL; ONDANSETRON; PYRIDOXIN HYDROCHLORIDE; TEMOZOLOMIDE; THIAMINCHLORIDE-HYDROCHLORIDE; TUMERIC
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 53