MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/10/2024

Event Type  Injury  

Event Description

A 47-year-old male patient with who grade iv anaplastic astrocytoma began optune gio therapy on (b)(6) 2021.On (b)(6) 2024, novocure was informed that the patient underwent plastic surgery for wound closure of his surgical resection site scar (last surgical resection on (b)(6) 2021).Optune gio therapy was discontinued.The patient was initially hospitalized between (b)(6) until (b)(6) 2024 for wound closure of his surgical resection site scar with a skin defect measuring 5x5 mm.The surgery was postponed due to multiple epileptic seizures during the hospitalization.On (b)(6) 2024, the patient was hospitalized again for surgical wound reconstruction using rotational flaps.Surgery was performed on (b)(6) 2024.Following surgery, the patient received antibiotics.On (b)(6) 2024, the patient was discharged to home, with skin graft in good condition with no signs of dehiscence.On (b)(6) 2024, novocure was informed that the patient had been hospitalized since (b)(6) 2023, due to tachycardia, seizures and poor saturation.On (b)(6) 2024, patient´s mother reported that the patient has suffered a severe stroke and was in the intensive care unit.Later that day his mother announced that the patient died on (b)(6) 2024.No further details are available at this time.The prescribing physician was contacted for further details without reply.

Manufacturer Narrative

Novocure medical opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.The events of seizure, tachycardia, poor saturation, stroke and death were not related to optune gio therapy.Contributing factors for wound dehiscence in this patient include: concomitant 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 surgeries affecting skin integrity.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).

• 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: 18853865
• MDR Text Key: 337071574
• Report Number: 3010457505-2024-00260
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107981194
• UDI-Public: (01)07290107981194(11)151227
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

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: TFH9100EU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2015
• 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: CEFUROXIME.; CLONAZEPAM.; DEXAMETHASONE.; LAMOTRIGINE.; LOMUSTINE.; RIVAROXABAN.; TEMOZOLOMIDE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male