MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

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 09/05/2023

Event Type  Injury  

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 dehiscence and wound infection in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information),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 is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).Wound infection is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).

Event Description

A 60-year-old male with glioblastoma began optune gio therapy on (b)(6) 2022.On august 18, 2023, novocure was informed that the patient developed a sore on the top of his head.Optune gio therapy had been temporarily discontinued on (b)(6) 2023.On october 03, 2023, novocure received a medical record from august 2023, documenting that patient will be referred to plastic surgery for closure of a wound involving the vertex of the scalp.The patient reported on october 02, 2023, that he recently had plastic surgery and planned to resume optune therapy once healed.Per medical record received on november 29, 2023, the patient experienced a bifrontal scalp wound with progressive scalp dehiscence in (b)(6) 2023, that required a wound revision on (b)(6) 2023.Bevacizumab had been held since august 17, 2023.During a post operative visit on (b)(6) 2023, the physician noted that the scalp wound was healing well, and that bevacizumab would be resumed.The patient notified novocure on november 14, 2023, that he experienced an unspecified infection, had several appointments, one of which was with infectious disease.On (b)(6) 2023, the patient reported he had been transitioned to a rehabilitation facility to monitor an infection that developed in the surgical incision area.After appointments with the healthcare provider, dermatologist, and wound care specialists it was determined that the infection had spread to the wound and bone.After several attempts of contact, the prescribing physician did not provide a causality assessment for the events.

Manufacturer Narrative

Novocure received additional information from the patient's caregiver on february 6, 2024, that the patient underwent additional brain surgery on (b)(6) 2024, that included a craniectomy.Postoperatively, the patient lost mobility and ability to speak.The patient was hospitalized for two weeks and transitioned to a rehabilitation facility after discharge.Optune gio therapy was permanently discontinued.

• Brand Name: OPTUNE GIO
• Type of Device: OPTUNE GIO
• 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: 18363447
• MDR Text Key: 330985088
• Report Number: 3010457505-2023-00252
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: (01)07290107982221(21)TFH212974(11)201222
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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: ATORVASTATIN.; BEVACIZUMAB.; DEXAMETHASONE.; FAMOTIDINE.; LEVETIRACETAM.; SOLIFENACIN.; TAMSULOSIN.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male