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); Post Operative Wound Infection (2446)

Event Date 03/03/2023

Event Type  Injury  

Event Description

A 45-year old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6), 2023.On (b)(6), 2023, the patient reported she was hospitalized due to an open area on her surgical resection site scar (last surgical resection (b)(6), 2022).According to the discharge letter from (b)(6), 2023, patient was hospitalized from (b)(6), until (b)(6), 2023.The patient presented with a pinhead-sized wound dehiscence located mid/left-frontal with exposed hardware cad (computer aided design) plastic implant and clear fluid discharge without evidence of purulence.The wound dehiscence was first present approximately three weeks prior.Patient was hospitalized due to suspected wound infection.On (b)(6), 2023, the patient underwent surgical removal of the cad-plastic implant and insertion of a drain without post-operative complications.Intraoperatively, there was no indication of a wound infection and during hospitalization there was no microbiological evidence of infection, thus the drain was removed without replacement.The intravenous administration of antibiotic therapy (cefuroxim) was discontinued after 48 hours.The patient was discharged on (b)(6), 2023, with planned suture removal on (b)(6), 2023.Per the prescribing physician, the patient had recurrent wound healing disorders requiring bone flap removal on (b)(6), 2022, followed by wound revision due to wound dehiscence on (b)(6), 2022.On (b)(6), 2022, cad-plastic was inserted.After completed wound healing, the patient started optune therapy with concomitant temozolomide in (b)(6) 2023.Approximately one month after starting optune, wound dehiscence was evident again.On (b)(6), 2023, the physician assessed purely in terms of image morphology, the dehiscence appeared more like a suture granuloma, especially since a wound infection was detected.To what extent the dehiscence was promoted by the arrays remains speculative according to the hcp.However, he could not exclude a contribution of ttfields to the event, as the wound dehiscence was present in the area of the arrays.

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound dehiscence and wound infection cannot be ruled out.Contributing factors for wound infection and wound dehiscence in this patient include: prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.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 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.

• 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: 16643662
• MDR Text Key: 312305024
• Report Number: 3010457505-2023-00231
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• 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: TFH9100EU
• Device Lot Number: N/A
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2017
• 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: CITALOPRAM; LEVOTHYROXINE; METFORMIN HYDROCHLORIDE; METOCLOPRAMIDE; METOPROLOL SUCCINATE; TEMOZOLOMIDE; VITAMIN D
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female