MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH-9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Additional contributing factors for wound dehiscence 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.There were no reports of wound dehiscence in the (b)(6) 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) 2017.On (b)(6) 2018, patient was hospitalized due to wound dehiscence with the bone cement visible under the resection scar (most recent tumor resection: (b)(6) 2018).Wound revision and removal of bone cement was performed on (b)(6) 2018.Post-operative wound healing was without complications and patient was discharged on (b)(6) 2018, with suture still in place.Treating physician was contacted for additional information; he provided the hospital summary but did not provide a causality assessment.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa 31905 ; 9724850120
• MDR Report Key: 7702348
• MDR Text Key: 114422869
• Report Number: 3009453079-2018-00106
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2018

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: 8 MO
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; DEXAMETHASONE; ENOXAPARIN SODIUM; L-THYROXINE; LEVETIRACETAM; METHADONE; METOCLOPRAMIDE; PANTOZOL; RAMIPRIL; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR