MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

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

Patient Problems Seizures, Focal (2260); Post Operative Wound Infection (2446)

Event Date 10/04/2015

Event Type  Injury  

Manufacturer Narrative

Novocure agrees with the prescribing physician that the wound infection was possibly related to optune therapy.Seizures were not related to optune therapy.Other contributing factors for wound infection in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications source: bevacizumab prescribing information), chronic steroid therapy, diabetes, underlying cancer disease and prior radiation.Wound infection was not 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.There have been 8 reports of wound infections reported in the commercial program to date.Seizures were reported in the ef-14 trial in both arms of the trial (16% optune/tmz and 18% tmz alone).

Event Description

Patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2015.On (b)(6) 2015, the patient's daughter reported that the patient had swelling at the surgical resection site (surgery performed on (b)(6) 2015).On (b)(6) 2015 patient presented to the neuro-oncology clinic with exudative drainage from the prior craniotomy incision.Optune therapy was discontinued upon admission.Patient underwent wound and epidural washout, craniectomy, and bone edge debridement that same day.Pathology tested positive for propionibacterium acnes.Patient was started on vancomycin 750 mg q12 hour.On (b)(6) 2014, picc line was placed.On (b)(6) 2015, patient was discharged home on vancomycin via picc line and advised to wear a helmet while ambulating due to missing bone flap.On an unknown date, patient was switched to ceftriaxone 2grams q12 hour.On (b)(6) 2014 the patient presented to the hospital in partial seizure status (new onset) on admission, with continued rhythmic shaking of left arm and leg, and then abdominal shaking.The patient was administered clonazepam (0.5 mg tid), lacosamide (100 mg bid) and levetiracetam (1000 mg bid) with no further seizure activity.In-patient intravenous antibiotics (for prior wound infection) were switched to iv penicillin 4x daily due to possible seizure threshold reduction with ceftriaxone.Mri showed interval increase in size of large enhancing mass.On (b)(6) 2015, patient underwent tumor resection surgery.Post op course was complicated by left sided flaccid paralysis.Patient was discharged on (b)(6) 2015 to home hospice care on anti-epileptics, steroids and iv antibiotics.Prescribing physician stated that optune therapy may have attributed to the infection, but the actual issue was a deeper infection that came up to the surface.Seizures were assessed as related to gbm progression.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer (Section G): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5220138
• MDR Text Key: 31012126
• Report Number: 3009453079-2015-00064
• Device Sequence Number: 1
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• 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: 10/16/2015

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-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 5 MO
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2015
• 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: VALACYCLOVIR
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR