MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH9100

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

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Novocure's medical opinion is that a contribution of the array placement to wound infection and wound dehiscence cannot be ruled out.Contributing factors for wound infection and wound dehiscence in this patient also include concomitant bevacizumab (vegf inhibitor which carries a black box warning for surgery and wound healing complication.Source: bevacizumab prescribing information), carmustine (impaired intracranial wound healing has been reported as an adverse event in 16% of patients with newly diagnosed gbm treated with carmustine wafers.Source: carmustine prescribing information), radiation and chemotherapy.Wound infection is an expected event with device use and was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).Wound dehiscence was reported as an adverse event in the ef-14 trial in the optune/tmz arm of the trial (<1%) only.Novocure's medical opinion is that cerebrospinal fluid leakage is not related to optune therapy but is related to carmustine (cerebrospinal fluid leakage is a known adverse event reported in 5% of patients.Source: carmustine package insert) and bevacizumab.Cerebrospinal fluid leakage was not reported as an adverse event in the ef-14 trial.There have been nine (<1%) reports of cerebrospinal fluid leakage in the commercial program to date.

Event Description

A (b)(6) year old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.On (b)(6) 2020, novocure was informed by the treating physician that the patient was admitted to the hospital on (b)(6) 2020, due to wound infection and cerebrospinal fluid leakage from a skin fistula secondary to endocranial sutural insufficiency from carmustine wafer implantation.Optune therapy was discontinued.Antibiotic treatment was started.On (b)(6) 2020, patient underwent surgery for bone flap removal and closure of the cerebrospinal fluid leakage.Per prescriber, concomitant bevacizumab, carmustine, radiation, and optune contributed to the wound infection and wound dehiscence with subsequent cerebrospinal fluid leakage.

Manufacturer Narrative

Novocure is submitting a follow up mdr to correct information in section b5.A 46 year old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020.On (b)(6) 2020, novocure was informed by the treating physician that the patient had been admitted to the hospital on (b)(6) 2020, due to wound infection.Antibiotic treatment was started and optune therapy was discontinued.On (b)(6) 2020, the patient underwent surgery for bone flap removal and closure of a skin fistula secondary to endocranial sutural insufficiency from carmustine wafer implantation (date of implantation unknown).On (b)(6) 2020, the prescribing physician clarified that there had been cerebrospinal fluid drainage from the skin fistula.Per prescriber, concomitant bevacizumab, carmustine, radiation, and optune contributed to the wound infection and wound dehiscence with subsequent cerebrospinal fluid leakage.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth, nh
• MDR Report Key: 10092260
• MDR Text Key: 194970819
• Report Number: 3009453079-2020-00147
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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: TFH9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 31 MO
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEVACIZUMAB; CARMUSTINE; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR