MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factor 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 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 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.
Event or Problem Description
A 78-year-old female with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2020.Novocure was informed on (b)(6) 2023, that the patient had plastic surgery scheduled the following day for a chronic open sore on the surgical resection site (last surgical resection (b)(6) 2020).Optune therapy was temporarily discontinued.In the photo provided there appeared to be a wound dehiscence on the surgical resection scar.On (b)(6) 2023, the patient reported the surgeon cleared her to resume optune therapy.After several attempts of contact, the prescribing physician did not provide a causality assessment for the event.
Additional Manufacturer Narrative
On april 26, 2023, additional information was discovered during review of an available medical record.The patient reported an open sore adjacent to the surgical resection scar on (b)(6) 2023.The patient underwent operative debridement, removal of periosteum to outer cortex of calvaria with removal of cranial hardware, and complex closure by plastic surgery on (b)(6) 2023.It was noted the sore developed in an area that occasionally optune adhesive covered.As the incision was near the crown of the head and healing well, optune therapy was able to be resumed by adjusting the arrays around the affected area.
Additional Manufacturer Narrative
On may 23, 2023, novocure discovered that the medical device report follow-up #1, section g-4, combination product was selected in error.

• Brand Name: OPTUNE
• Common Device Name: 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: 16831464
• Report Number: 3010457505-2023-00235
• Device Sequence Number: 15249143
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 05/23/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/23/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL.; ASPIRIN.; BEVACIZUMAB.; BUDESONIDE-GLYCOPYRROLATE-FORMOTEROL.; CITALOPRAM.; CLOBETASOL.; DEXAMETHASONE.; FUROSEMIDE.; LEVOTHYROXINE.; LISINOPRIL.; METHYLPHENIDATE.; POTASSIUM CHLORIDE.; PROCHLORPERAZINE.; SODIUM CHLORIDE.; SPIRONOLACTONE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female