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 05/15/2023

Event Type  Injury  

Event Description

A 60-year old female patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.During a transducer array change on (b)(6) 2023, the patient's spouse observed the patient's surgical resection scar started to bleed and appeared inflamed.The patient was seen by the physician on (b)(6) 2023, who recommended to temporarily discontinue optune therapy until the wound was healed.Optune therapy was temporarily discontinued.On (b)(6) 2023, the patient's spouse reported that the patient was admitted to the hospital the day prior.Wound revision of the surgical resection site scar due to a wound healing issue was scheduled for (b)(6) 2023.According to medical records, patient was hospitalized previously on (b)(6) 2023 until (b)(6) 2023 due to suspected disease progression (optune therapy was temporarily interrupted as of (b)(6) 2023).The patient underwent a surgical revision on (b)(6) 2023, intraoperatively impression was old infected hematoma in the area of the previous resection cavity.Although intraoperative wound sap was negative for infection, oral antibiotics (moxifloxacin) were prescribed.Pathology showed a complete necrosis and partial inflammation of parenchyma and fresh blood.During a follow up visit with the physician on (b)(6) 2023, the wound appeared not irritated, no signs of wound dehiscence.The patient resumed optune therapy on (b)(6) 2023.According to patient's records, patient experienced wound healing issues prior to optune therapy ((b)(6) 2022), which resolved prior to optune therapy start.The prescribing physician was contacted for further details for the event, without reply.

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: prior wound healing issues, prior radiation, underlying cancer disease, prior surgeries affecting skin integrity, and prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information).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.

Manufacturer Narrative

Novocure received additional information from the patient on (b)(6) 2023, that patient´s wound healing disorder required further surgical intervention on (b)(6) 2023.The neurosurgeon noted that the wound has not completely closed and thus required re-suturing.The neurosurgeon advised the patient to remain off therapy for at least 4 more weeks.Optune therapy is discontinued since (b)(6) 2023.

Manufacturer Narrative

Novocure received additional information from the prescribing physician on june 15, 2023, that the patient experienced a wound dehiscence with infection.The patient presented for a follow up visit on may 15, 2023, following a removal of exposed subcutaneous sutures on (b)(6) 2023.The physician noted a right parietal wound dehiscence over 5mm in length, weeping, no purulence, with increased redness of the adjacent soft tissue.Due to the dehiscence, weeping, and increased inflammatory wound healing disorder the patient underwent surgical intervention on (b)(6) 2023.Intraoperative cultures obtained from the wound revealed staphylococcus epidermis which were treated postoperatively with (ampicillin/sulbactam) for three days.The physician assessed the cause of the event as the high number of follow-up operations in combination to transducer array placement in the poorly healing wound area.Novocure´s medical opinion is that a contribution of the arrays cannot be ruled out.Contributing factors for wound infection in this patient include: prior radiation, underlying cancer disease, and multiple surgeries 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).

• 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: 17115319
• MDR Text Key: 317038292
• Report Number: 3010457505-2023-00238
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DALTEPARIN SODIUM; DEXAMETHASONE; LEVETIRACETAM; LORACEPAM; METAMIZOLE; MOXIFLOXACIN; PANTOPRAZOLE; SULFAMETHOXAZOL-TRIMETHOPRIM; TEMOZOLOMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female