MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH9100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Contributing factors for skin erosion in this patient include: dexamethasone use (impaired wound healing is listed as a side effect.Source: dexamethasone prescribing information), radiation, chemotherapy and prior surgery affecting skin integrity.Skin erosion was reported as an adverse event in the ef-14 trial in the tmz arm of the trial (<1%) only.There have been three prior reports of skin erosion requiring shunt removal/revision in the commercial program to date.Scalp necrosis is a known complication of vp shunt placement.Vp shunt complications have been reported in the literature as occurring in 11.8% of patients with brain tumors, with 6.7% of patients requiring shunt removal (source: nigim et al, oncology, 2015, 3:1381-1386).

Event Description

A (b)(6) year-old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2020.Per medical records, patient underwent ventriculoperitoneal (vp) shunt placement (b)(6) 2020 for pseudomeningocele at the craniectomy surgical incision site (last surgical resection (b)(6) 2019).On (b)(6) 2020, during a telemedicine follow up patient visit, the patient reported swelling at the craniectomy incision site.Prescriber observed fluid collection upon examination.On (b)(6) 2020, novocure was informed by the patient that the vp shunt needed to be surgically removed due to damage from optune therapy.On july 15, 2020, novocure was informed that the patient had developed a skin reaction on the scalp at the vp shunt implantation site.Optune therapy was permanently discontinued.Prescribing physician was contacted for additional information and causality assessment with no response.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; 195 commerce way; portsmouth, nh
• Manufacturer (Section G): NOVOCURE, LTD.; 195 commerce way; portsmouth, nh
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, nh ; 3191907
• MDR Report Key: 10420247
• MDR Text Key: 209405256
• Report Number: 3009453079-2020-00153
• 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: 08/18/2020

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
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 82