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); Ulcer (2274); Post Operative Wound Infection (2446)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution of the array placement to the ulceration cannot be ruled out.Contributing factors for medical device site ulcer in this patient include concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity.Medical device site ulcer 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 the optune arm of the trial (<1%).

Event Description

A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2019.Per medical records, on (b)(6) 2020, prescribing physician noted that the patient had developed an ulcer on the scalp near the craniotomy surgical resection site (last surgical resection (b)(6) 2018).The patient was instructed to temporarily discontinue optune therapy, continue treating the affected area with a topical ointment (muciprocin), and consult with dermatology for further treatment.On (b)(6) 2020, during a scalp re-check appointment, it was noted that the ulcerative lesion had scabbed but remained raised.A new transducer array map prescription was provided to avoid the raised area on the scalp and the patient resumed optune therapy in (b)(6) 2021.On (b)(6) 2021, the patient presented for evaluation due to re-opening of the scalp lesion with exposed cranium surgical mesh, surrounding erythema, thick green drainage and slough within the wound bed.Scalp wound dressings had been removed and changed every 3 days along with the transducer arrays.On (b)(6) 2021, neurosurgery notes described skin breakdown of the scalp measuring approximately 3 to 4 cm in diameter without erythema or purulence.The patient denied recent fevers, headaches, seizures or mental status changes.Neurosurgery determined that the patient would need wound revision surgery to remove the cranium hardware and debride the wound area.Prescribing physician did not provide a causality assessment.

Manufacturer Narrative

Novocure received additional information that the patient was admitted to the hospital on (b)(6) 2021, for wound debridement, cranium hardware (plate) removal, and wound closure.On (b)(6) 2021, the patient was discharged home in stable condition.The event was complicated by a wound infection that was treated with antibiotics (linezolid/ciprofloxacin/ceftriaxone) to good effect.On (b)(6) 2021, the patient underwent wound debridement with rotational flap closure.On (b)(6) 2021, optune therapy was temporarily discontinued.On (b)(6) 2021, the prescriber noted that the scalp wound was approximately an eraser sized open area at the right frontal scalp.Wound borders were smooth without signs of infection or abscess.The patient was instructed to re-start optune therapy with a new transducer array layout mapped to avoid the non-healing open area on the scalp.During an office examination on (b)(6) 2021, the prescriber noted the right frontal wound appeared slightly larger.On (b)(6) 2021, novocure received a report that the patient's wound re-opened and became worse.On (b)(6) 2021, patient reported he ended optune therapy.On (b)(6) 2021, prescribing physician assessed the cause of the event to pressure from optune on the scalp and patient using the device regularly for a number of months at high proportions.Previous bevacizumab could have also contributed.Novocure's opinion is that a contribution of the array placement to the wound dehiscence and wound infection cannot be ruled out.Contributing factors for wound infection and wound dehiscence in this patient include history of concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab 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 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, NH 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 6033191907
• MDR Report Key: 11667445
• MDR Text Key: 261717711
• Report Number: 3009453079-2021-00170
• 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
• Report Date: 12/14/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2016
• 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.; CARVEDILOL.; LEVETIRACETAM.; LISINOPRIL.; ONDANSETRON.; RIVAROXABAN.; RIVAROXABAN.; SIMVASTATIN.; SYNTHETIC CANNABINOIDS.; TEMOZOLOMIDE.; TRAZODONE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 86 KG