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 11/01/2021

Event Type  Injury  

Event Description

A (b)(6) female with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2021.On (b)(6) 2021, the spouse reported to novocure that the patient temporarily discontinued optune therapy due to an infection at the craniotomy surgical incision site.Patient was treated with an unspecified medication for 25 days.On (b)(6) 2021, the prescribing physician reported that on an unspecified date, the patient was hospitalized and underwent surgery for management of a craniotomy wound dehiscence.Prescriber assessed the cause of the event to be related to prior craniotomy ((b)(6) 2021), radiation, use of bevacizumab, dexamethasone, and optune therapy.

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to the events 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 is listed as a side effect.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 (b)(4) 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 in the optune/tmz arm of the trial (1%) only.

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to the events 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 is listed as a side effect.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 (b)(4) 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 in the optune/tmz arm of the trial (1%) only.

Event Description

A (b)(6) female with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2021.On (b)(6) 2021, the spouse reported to novocure that the patient temporarily discontinued optune therapy due to an infection at the craniotomy surgical incision site.Patient was treated with an unspecified medication for 25 days.On (b)(6) 2021, the prescribing physician reported that on an unspecified date, the patient was hospitalized and underwent surgery for management of a craniotomy wound dehiscence.Prescriber assessed the cause of the event to be related to prior craniotomy ((b)(6) 2021), radiation, use of bevacizumab, dexamethasone, and optune therapy.

• 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: 12821518
• MDR Text Key: 285737845
• Report Number: 3010457505-2021-00191
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107982221
• UDI-Public: 07290107982221
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2021

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
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• 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: BEVACIZUMAB.; DEXAMETHASONE.; ONDANSETRON.; SIMVASTATIN.; TEMOZOLOMIDE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 55 KG