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); Abscess (1690); Post Operative Wound Infection (2446)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to the wound dehiscence, wound infection and abscess 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), 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 surgery affecting skin integrity.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.Wound infection is an expected event with device use and was reported in the ef-14 trial in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).Abscess is an expected event with device use and was reported in the ef-14 trial in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2021.On (b)(6) 2021, during a follow-up office visit, patient presented with a focal area of erythema, swelling, and pustule formation at the surgical resection incision (last surgical resection (b)(6) 2021).Intermittent drainage of purulent fluid from the wound was noted.Patient was prescribed antibiotics (sulfamethoxazole-trimethoprim).Optune therapy was temporarily discontinued and resumed on (b)(6) 2021.During a phone encounter with the prescriber on (b)(6) 2021, spouse noted the patient experienced increased drainage and worsened wound issues.Prescriber advised temporarily discontinuing bevacizumab and proceeding with surgical exploration.On (b)(6) 2021, patient was admitted and underwent re-opening, debridement, irrigation, drainage, and re-closure of the craniotomy wound.During the surgery a subgaleal focal infection was discovered.Intra-operative cultures of purulent fluid grew normal flora.Patient was treated post-operatively with intravenous (iv) antibiotics (vancomycin 1500 mg).Post-operative fluid drain was removed on (b)(6) 2021.On (b)(6) 2021, a mid-line catheter was placed and patient was discharged home with instructions for home health to administer iv vancomycin for two weeks and continue with steroid medication (dexamethasone 1.5 mg 2x daily).On (b)(6) 2021, upon admission from the emergency department (ed) following a syncopal event and fall unrelated to device use, the patient was noted to have transient drainage of fluid from the scalp.Subgaleal collection of fluid with pain had developed at the surgical resection site.On (b)(6) 2021, neurosurgery aspirated 18 ml of tan purulent-appearing liquid percutaneously.Anaerobic cultures revealed prevotella buccae and skin flora.On (b)(6) 2021, patient underwent wound revision surgery, removal of cranial bone flap and drainage of brain abscess.Cultures only showed skin flora.Patient was instructed to continue with current vancomycin dose, increase ceftriaxone to 2g q 12 hours and add an oral antibiotic (metronidazole 500 mg) to treat anaerobic bacteria.Antibiotic regimen was planned until (b)(6) 2021.Per prescribing physician, patient had developed a small area of wound dehiscence during radiation and had been closely monitored.Wound complication was likely caused by chronic bacterial infection, combined with radiation and steroid use.Not likely related to optune therapy.The patient remains on treatment break with optune therapy until suture removal planned in 2-3 weeks.

• 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: 12494908
• MDR Text Key: 272133451
• Report Number: 3009453079-2021-00184
• Device Sequence Number: 1
• Product Code: NZK
• 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: 09/20/2021

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: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2016
• 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; CLONAZEPAM; DEXAMETHASONE; DICLOFENAC; FLUOXETINE; GABAPENTIN; GLIMEPIRIDE; HYDROCODONE-ACETAMINOPHEN; INSULIN; LEVETIRACETAM; LISINOPRIL; LORAZEPAM; MELOXICAM; METFORMIN; PREVASTATIN; TEMOZOLOMIDE; ZOLPIDEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 98