MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Ulcer (2274)

Event Date 10/15/2021

Event Type  Injury  

Event Description

On august 08, 2021, the spouse informed novocure that the patient developed redness and pain with an open area at the craniotomy resection site (latest resection, (b)(6) 2021).On (b)(6) 2021, during an office visit to evaluate the surgical resection incision, the prescriber noted an area of ulceration at the inferior aspect of the recent craniotomy incision underlying the optune transducer array.The prescriber instructed the patient to temporarily discontinue optune therapy for two weeks and treat the affected area with a topical antibiotic ointment (mupirocin).On (b)(6) 2021, the prescriber confirmed that the patient was not hospitalized for the wound dehiscence and no infection was noted.Patient was on bevacizumab and dexamethasone at the time.Cause of the event was due to the recent resection surgery and overlying optune.On october 15, 2021, the spouse reported that the patient underwent surgery on (b)(6) 2021, due to ongoing skin issues that resulted in a subsequent wound complication.Optune therapy was discontinued with the possibility of resuming therapy after the wound fully healed.On (b)(6) 2021, the prescriber reported the patient had developed an ulcer at the inferior aspect of the craniotomy incision.Patient was hospitalized and underwent surgical debridement and washout.Cause of the event was a combination of bevacizumab and optune therapy.

Manufacturer Narrative

Novocure's medical opinion is that a contribution of the arrays to medical device site ulcer cannot be ruled out.Contributing factors for medical device site ulcer in this patient include: underlying cancer disease, prior surgery affecting skin integrity, bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), and dexamethasone use (impaired wound healing is listed as a side effect, source: dexamethasone prescribing information).Medical device site ulcer 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 the optune arm of the trial (<1%).

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 12778791
• MDR Text Key: 284133743
• Report Number: 3010457505-2021-00189
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/09/2021

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: TFH9100US
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BEVACIZUMAB; BUDESONIDE; CHOLECALCIFEROL; DEXAMETHASONE; DIPHENHYDRAMINE; MESALAMINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 47 KG