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 06/28/2022

Event Type  Injury  

Manufacturer Narrative

Novocure opinion is that the contribution of the array placement to wound infection and wound dehiscence cannot be ruled out.Contributing factors for wound infection and wound dehiscence in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), 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.

Event Description

A 57-year-old male patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2021.On (b)(6) 2022, novocure was informed by the spouse that the patient had a "pus" filled bump on his scalp.On the same day, the prescribing site nurse reported the patient had a "mushy" spot on his head that was swollen, dark red, and appeared ready to rupture.The neurosurgeon prescribed antibiotics (amoxicillin/clavulanate potassium) for 14 days due to a possible infection.Optune therapy was temporarily discontinued.On (b)(6) 2022, the patient presented to emergency department with draining wound on crown of the head.The wife reported a small area of dehiscence on the center of the surgical incision (last surgical resection (b)(6) 2021 that began draining approximately two weeks prior.Mri and ct negative for intracranial abscess, and after discussion with infectious disease, out of concern for latent osteomyelitis, decision for surgery was made.A boil on top of the head ruptured releasing purulent drainage.Prior prophylactic prescription for sulfamethoxazole-trimethoprim had been provided to the patient, wife reported the patient had been off for 3 weeks.Wound cultures grew staphylococcus and candida albicans on (b)(6) 2022.Piperacillin/tazobactam and vancomycin started in emergency department, and changed to ceftazidime, vancomycin, and fluconazole per infectious disease, patient admitted on this day.On (b)(6) 2022, patient underwent left frontal craniectomy of 11cm complex scalp wound, removal of bone flap, cranial hardware and exploration of intradural space for brain infection.Evident purulence was expressed once bone flap removed, no focal fluid collections in the scalp or extra-axial space.Extra-axial drain placed in surgical bed for serosanguineous fluid evacuation removed, and wound closure performed with plastic surgery.Port catheter antibiotics were infused per infectious disease instruction.On (b)(6) 2022, patient discharged home in stable condition with instructions to continue a six to eight week course of outpatient intravenous (iv) antibiotic therapy.No causality assessment from prescriber is available.

Manufacturer Narrative

On july 19, 2022, novocure discovered that the initial submitted medical device report submission date was incorrect.The correct submission date is july 19, 2022.

Manufacturer Narrative

On february 14, 2024, novocure has discovered that the pma/510(k) in section g4 was incorrect 1.In addition the udi # in section d4 was corrected.

• 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: 15051286
• MDR Text Key: 296132198
• Report Number: 3010457505-2022-00213
• 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,Followup,Followup
• Report Date: 03/01/2024

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
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 02/14/2024
• Supplement Dates FDA Received: 08/09/2022; 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2019
• 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: ATORVASTATIN; BEVACIZUMAB; DEXAMETHASONE; ESCITALOPRAM OXALATE; FLUCONAZOLE; INSULIN ASPART; INSULIN DEGLUDEC; LEVETIRACETAM; LIRAGLUTIDE; MIRTAZAPINE; OMPERAZOLE; ONDANSETRON; TELMISARTAN; TEMMZOLOMIDE; TRAZADONE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 201 KG