MAUDE Adverse Event Report: NOVOCURE, LTD. OPTUNE

Model Number TFH-9100

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

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Date 11/06/2018

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 wound dehiscence and skin erosion in this patient include: dexamethasone use (impaired wound healing is listed as a side effect.Source: dexamethasone prescribing information), radiation, chemotherapy, prior surgery, and prior surgical shunt revision affecting skin integrity.Wound dehiscence was reported as an adverse event in the (b)(6) 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.Skin erosion was reported as an adverse event in the (b)(6) trial in the tmz arm of the trial (<1%) only.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) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018, as part of the (b)(6).On (b)(6) 2018, the prescriber contacted novocure reporting that patient had beginning wound dehiscence around the ventriculoperitoneal (vp) shunt implantation site approximately 3cm behind the right ear (surgical revision of shunt system (b)(6) 2018, after hospitalization due to hydrocephalus).Optune therapy had been temporarily discontinued on (b)(6) 2018.According to the prescriber, therapy could be resumed if affected skin area was not covered by the ine transducer arrays.On (b)(6) 2018, patient's spouse reported that patient was hospitalized due to headache.Per hospital summary, patient presented at the hospital on (b)(6) 2018 due to persisting headaches (beginning four days prior).Head ct and mri were positive for progression of intraventricular glioma with new lesions detected along the ventricles (left frontal and left cerebellar).Headaches improved after administration of analgesics and dexamethasone (4mg tid) and patient was discharged home on (b)(6) 2018.The prescriber assessed the headache as not related to optune therapy.Optune therapy was resumed on (b)(6) 2018.On (b)(6) 2018, patient's spouse reported that the skin around the scar, which had not been covered by ine transducer arrays since optune therapy was resumed, was not healed yet.Optune therapy was again discontinued on (b)(6) 2018.On (b)(6) 2018, spouse reported that patient had been hospitalized because a new shunt had been implanted.On january 02, 2019, novocure received the sae report for this hospitalization.On january 03, 2019, the investigator provided the hospital summary, which stated that on (b)(6) 2018, patient had presented to the emergency department with necrotic skin behind the right ear (approximately 1x1cm) with an exposed shunt catheter.Head ct was negative for tumor progression, but showed hydrocephalus.Patient underwent surgical vp shunt removal and external ventricular drain placement the same day without complications.Postoperative head ct showed an improvement of the hydrocephalus.On (b)(6) 2018, a left frontal vp shunt with gravitational valve was implanted.Due to advanced tumor progression and switch to palliative care, no further therapy was indicated.Patient was discharged home on (b)(6) 2018 in good general condition.At the time of the report (january 02, 2019), the prescriber assessed the events as unrelated to optune therapy.On january 29, 2019, the prescriber revised the causality assessment, stating that the events were related to optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE, LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa 31905 ; 9724850120
• MDR Report Key: 8292600
• MDR Text Key: 134594229
• Report Number: 3009453079-2019-00113
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2019

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: TFH-9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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: DEXAMETHASONE; ENOXAPARIN SODIUM; PANTOZOLE; PARACETAMOL; RANITIDINE HYDROCHLORIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 49