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 02/09/2023

Event Type  Injury  

Event Description

A 45-year old female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2021.On (b)(6) , the patient provided pictures of her scalp showing the surgical resection site scar (last surgical resection (b)(6) 2022) with visible cranial hardware.The patient reported that the area was weeping occasionally and being treated with an unspecified solution.On (b)(6) 2023, after consulting with the physician, she was referred to the hospital for further treatment.Patient stopped optune therapy as of (b)(6) 2023.The patient presented to the hospital with complaints of several weeks of wound drainage.The patient denied headache, nausea, fever and experienced no related wound pain.The wound appeared slightly reddened with two open areas and a visible titanium clamp system.Applying pressure led to a purulent drainage.The patient was admitted for the wound healing disorder and wound dehiscence.On (b)(6) 2023, the patient underwent wound revision surgery and removal of surgical hardware (calotte piece).Postoperatively, the patient received intravenous antibiotic treatment (fosfomycin and sultamicillin).Following the surgery, the wound healed without irritation and was dry.On (b)(6) 2023, the patient was discharged on antibiotic treatment of amoxicillin/clavulanic acid and clindamycine until suture removal planned for (b)(6) 2023.On (b)(6) 2023, patient´s spouse reported the patient experienced tumor progression, remained hospitalized and used crutches to aid with walking.The prescribing physician did not provide additional information or causality assessment.

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 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 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: 16501553
• MDR Text Key: 310864482
• Report Number: 3010457505-2023-00228
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• 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: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• 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: DEXAMETHASONE.; LEVETIRACETAM.; METAMIZOLE.; PANTOPRAZOLE.; REGORAFENIB.; TEMOZOLOMIDE.; ZOPICLONE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female