MAUDE Adverse Event Report: NOVOCURE LTD NOVOTTF-100A

Model Number TFH-9000

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

Patient Problem Respiratory Failure (2484)

Event Date 07/28/2014

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the events were not related to novottf therapy.Respiratory failure was not reported as an adverse event in the pivotal phase iii recurrent glioblastoma trial or in the pivotal phase iii recurrent glioblastoma trial or in the commercial program to date.Risk factors for respiratory failure in this pt include: history of pulmonary fibrosis and atelectasis, aspiration pneumonia secondary to dysphagia, pulmonary embolism and depressed level of consciousness secondary to underlying disease (recurrent glioblastoma).

Event Description

Pt with recurrent glioblastoma began novottf therapy on (b)(6) 2014.On (b)(6) 2014, pt presented on the hosp following recurrent seizures (pt had a history of seizures and was on levetiracetam prior to the event).Pt was treated with 2mg lorazepam and levetiracetan dose was increased to 1000mg bid with no further seizures.Computerized tomography (ct) of the head revealed a cyctic lesion in the right parietal region with vasogenic edema (no significant changes from last mri performed (b)(6) 2014).Pt was hypoxemic and respiratory acidotic with a significant volume of secretions in his upper airway.It was considered that he may require intubation.He was managed with frequent suction, oral bite block and nonrebreather mask leading to improvement in oxygenation and was moved to the intensive care unit.He subsequently became hypotensive likely secondary to aspiration pneumonia and underwent central line placement due to poor peripheral access.His respiratory distress worsened requiring intubation and ventilator support.Pt has a past history of atrial fibrillation for which he was receiving anti-coagulation with warfarin.His inr was 3.1.Anticoagulation was discontinued and inr was allowed to fall to below 1.7 prior to an uncomplicated tracheostomy placement on (b)(6).Electroencephalograms (eegs) performed on (b)(6) and (b)(6) were abnormal (epileptiform discharges and diffuse cerebral dysfunction noted).On (b)(6) 2014, pt was treated for ventilator associated stenotrophomonas maltophilia pneumonia with sulfamethoxazole / trimethoprim.At the time of the report, the pt was still hospitalized.Pt continued on novottf therapy throughout the hospitalization.Continuous transdermal.Therapy dates: (b)(6) 2014-present.Diagnosis for use: recurrent glioblastoma.

• Brand Name: NOVOTTF-100A
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg. sha'ar hacarmel; 4th floor; haifa 31905 ; IS 31905 ; 48501204
• MDR Report Key: 4181377
• MDR Text Key: 145514143
• Report Number: 3009453079-2014-00043
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2014
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR