MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

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	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure opinion is that contribution of the array placement to 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 surgery affecting skin integrity.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).
Event or Problem Description
A 66-year-old male with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2022.Novocure was informed on may 06, 2024, that the patient temporarily discontinued optune gio therapy due to skin irritation in the location of cranial hardware (screw).On may 20, 2024, the patient reported he had resumed optune gio therapy for one week, although had to repeatedly discontinue as a "hole" developed in the location of cranial hardware at the previous surgical resection site.It was reported that during a neurosurgeon evaluation on (b)(6) 2024, the skin in the region of previous surgery was very thin and during transducer array changes the skin pulled which resulted in a "hole" in the location of cranial hardware.In the provided image there was evidence of a wound dehiscence with exposed hardware.The physician advised to temporarily discontinue optune gio therapy until further evaluation on (b)(6) 2024.The prescribing physician was contacted for further details without reply.
Additional Manufacturer Narrative
Novocure received additional information on june 26, 2024, from the healthcare provider, that the patient was not hospitalized for the wound dehiscence and was not on steroids or bevacizumab, although was on lomustine at the time of the event.A contributing factor for the wound complication in this patient includes concomitant lomustine (carries a black box warning for myelosuppression, source: lomustine prescribing information).The prescribing physician and surgeon believed the event was related to optune gio therapy.On(b)(6) 2024, the patient permanently discontinued optune gio therapy under the advisement of the healthcare provider (hcp) due to skin reactions experienced while on therapy.Additional note: it was discovered that the date of birth (dob) in section a.2 was incorrect.The correct dob is (b)(6) 1958.

• Brand Name: OPTUNE GIO
• Common Device Name: OPTUNE GIO
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 19546837
• Report Number: 3010457505-2024-00287
• Device Sequence Number: 15132619
• Product Code: NZK
• UDI-Device Identifier: 07290107982214
• UDI-Public: (01)07290107982214(11)160816
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2016
• 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: ACETAMINOPHEN-CODEINE; ALBUTEROL SULFATE; ATORVASTATIN; BEVACIZUMAB; FLUCONAZOLE; HYDROXYZINE; LACOSAMIDE; LOMUSTINE; OLANZAPINE; ONDANSETRON; SERTRALINE; TRAZODONE; ZONISAMIDE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 68 KG