MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to the wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), prior radiation, underlying cancer disease and prior surgeries affecting skin integrity.Wound dehiscence 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 the optune/tmz arm of the trial (<1%) only.Cerebrospinal fluid leakage was not 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.There have been 18 reports of cerebrospinal fluid leakage in the commercial program to date.

Event Description

A (b)(6) old male with newly diagnosed glioblastoma started optune therapy on (b)(6) 2021.On (b)(6) 2021, the spouse reported to novocure that the patient had temporarily discontinued optune therapy due an issue with the surgical resection incision (last surgical resection (b)(6) 2021).The oncologist indicated that a wound revision may be required.On (b)(6) 2021, the prescriber reported that after the re-resection the patient was started on an unspecified steroid medication with concurrent bevacizumab.Evidence of a wound dehiscence was observed at the incision site however, no signs of infection were noted.Prescriber assessed the cause of the wound dehiscence as secondary to the recent tumor resection surgery and bevacizumab and less likely due to optune therapy.On (b)(6) 2021, the spouse provided additional information that the patient had underwent surgery eight to nine days prior due to skin break down at the surgical resection incision.On (b)(6) 2021, it was reported that during the prior week, the patient underwent shunt placement surgery due to a cerebrospinal fluid leakage.

Manufacturer Narrative

On september 21, 2021, novocure received additional information that the patient underwent surgical removal of the shunt that was placed for cerebrospinal fluid leakage.On (b)(6), 2021, the spouse reported due to ongoing issues with shunts, multiple surgeries, and infections, the patient was unable to continue with optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• MDR Report Key: 12456870
• MDR Text Key: 272135505
• Report Number: 3009453079-2021-00182
• 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: 10/15/2021

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
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABEMACICLIB; ATORVASTATIN; BEVACIZUMAB; DEXAMETHASONE; GABAPENTIN; LISINOPRIL; MELOXICAM; ONDANSETRON; SERTRALINE; SULFAMETHOXAZOLE-TRIMETHOPRIM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 79