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 06/22/2022

Event Type  Injury  

Event Description

A 57-year old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020, as part of the investigator sponsored trial "a phase i trial of novottf-200a prior and concomitant to radiotherapy and temozolomide in newly diagnosed glioblastoma".On (b)(6) 2022, the patient developed a wound dehiscence in the area of the surgical sutures (last surgical resection, (b)(6) 2022).On (b)(6) 2022, the patient presented with several surface level skin lesions, a 0.3cm x 03.Cm sized wound dehiscence and exposed screws in the right parietal aspect of the scalp.The dehiscence was slightly red and did not produce secretions when provoked.It did not cause pain or produce heat.Patient denied headaches, nausea, and vomiting.The patient was admitted to the department of neurosurgery.Optune was temporarily discontinued on (b)(6) 2022.The patient planned to pause therapy for at least three weeks.On (b)(6) 2022, the patient underwent wound revision surgery with wound debridement of the right parietal area and explantation of the bone plate.An intraoperative lab culture determined an infection of staphylococcus epidermidis, and the patient was started on intravenous antibiotics (piperacillin and tazobactam).The surgical site remained irritation-free after the operation.On (b)(6) 2022, the patient was discharged home on oral trimethoprim/sulfamethoxazole 960mg three times daily.Suture removal was scheduled for (b)(6) 2022.It was recommended to not resume optune due to the bone plate explantation.On (b)(6) 2022, novocure received a serious adverse event (sae) report.The investigators assessed that the transducer arrays covered the area where the wound dehiscence occurred, and therefore could not exclude the possibility that optune contributed to the adverse event.The prescriber assessed that optune therapy was a possible risk factor.

Manufacturer Narrative

Novocure opinion is that a contribution of the array placement to wound dehiscence and wound infection cannot be ruled out.Contributing factors for wound dehiscence and wound infection in this patient also include prior radiation, chemotherapy, underlying cancer, 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 in the optune/tmz arm of the trial (<1%) only.

Manufacturer Narrative

On (b)(6) 2022, novocure received additional information that the patient had additional surgery on an unspecified date.Reportedly, there was an area with exposed surgical hardware in the same location that a piece of bone was removed.The patient temporarily discontinued optune therapy.

Manufacturer Narrative

On december 07, 2022, novocure received additional information that the patient was experiencing a wound healing disorder.The patient planned to take an estimated 7 day optune treatment break to allow skin to heal.

• 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: 15003636
• MDR Text Key: 295811973
• Report Number: 3010457505-2022-00212
• 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,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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: IBUPROFEN.; LEVOTHYROXINE.; PANTOPRAZOLE.; TEMOZOLOMIDE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 71 KG