MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE GIO

Model Number TFH9100

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound infection cannot be ruled out.Contributing factors for 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 and underlying cancer disease.Programmable shunts are contraindicated with optune gio use.Wound infection is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).

Event Description

A 56-year-old female with newly diagnosed glioblastoma (gbm) started optune gio therapy (b)(6) 2023.On (b)(6) 2024, caregiver reported, that patient was pausing optune gio therapy due to a skin injury.On (b)(6) 2024, the patient´s spouse reported the patient underwent shunt revision surgery.Per available medical records from (b)(6) 2024, the patient developed a wound infection on (b)(6) 2024.The patient underwent vp shunt revision surgery on (b)(6) 2024.On (b)(6) 2024, the patient presented for a re-check, with healing scalp incision and sutures in place with no signs of infection or wound dehiscence.Optune gio was discontinued as of (b)(6) 2024.The prescribing physician was contacted for further details without reply.

• 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: 18938754
• MDR Text Key: 338068456
• Report Number: 3010457505-2024-00264
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)200610
• 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: Other
• Type of Report: Initial
• Report Date: 03/20/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2020
• 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: BEVACIZUMAB; CHLORHEXIDINE GLUCONATE; CLINDAMYCIN PHOSPHATE; DEXAMETHASONE; DOCUSATE SODIUM; ESTRADIOL; FAMOTIDINE; FUROSEMIDE; HYDROCORTISONE; LEVETIRACETAM; MEGESTROL ACETATE; OMEPRAZOLE; ONDANSETRON; PROGRAMMABLE VP SHUNT; SENNA GLYCOSIDE; SODIUM CHLORIDE; TEMOZOLOMIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female