MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE; OPTUNE, PRODUCT CODE: NZK

Model Number TFH-9000

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

Patient Problem Pulmonary Embolism (1498)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

Novocure concurs with prescribing physician that pulmonary embolism / deep vein thrombosis was related to patient's hypercoagulable state secondary to glioblastoma and was not related to optune therapy.Pulmonary embolism 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 (2% and 5% in optune/tmz and tmz arms respectively).Hypercoagulability and risk for venous thromboembolism in the setting of a cancer diagnosis and chemotherapy administration has been described extensively (e.G.Nccn guidelines 2014 - venous thromboembolic disease).In addition, multiple studies in the literature describe the incidence of pulmonary embolism in gbm patient population from 0.5 - 8%.

Event Description

Patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2015.On (b)(6) 2015, patient presented to an outside area hospital with shortness of breath.Chest x-ray showed right lobe infiltrate concerning for pneumonia.Patient was admitted for the treatment of community acquired pneumonia with ceftriaxone and levofloxacin.Oxygenation continued to worsen and chest ct revealed new onset saddle pulmonary embolus (pe).Patient was treated with heparin infusion and transferred to the intensive care unit at prescribing site for further care.Upon presentation, patient was experiencing shortness of breath due to hypoxemic respiratory failure secondary to pe and pneumonia.Patient was started on ceftriaxone and azithromycin for treatment of pneumonia and continued on heparin drip for anticoagulation.Doppler ultrasound showed deep vein thrombosis (dvt) in right lower extremity.Echocardiogram showed ejection fraction (ef) 60-65% with mild dilation of right ventricle.Patient was thrombocytopenic throughout course.Patient transitioned to enoxaparin and platelet level increased.On (b)(6) 2015, patient deemed medically stable and was transferred from the icu to hematology/oncology.Patient continued to show improvement and was discharged to rehabilitation on (b)(6) 2015.Patient did not have a history of pe/dvt and was not on anti-coagulation therapy at the time of the event.Per prescribing physician, the cause of the pe/dvt was patient's hypercoagulable state secondary to glioblastoma and decreased mobility.The event was not related to optune therapy.Patient continues with optune therapy.

• Brand Name: OPTUNE
• Type of Device: OPTUNE, PRODUCT CODE: NZK
• 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, is 31905 ; IS 31905
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905 ; 48501204
• MDR Report Key: 5263592
• MDR Text Key: 32594348
• Report Number: 3009453079-2015-00066
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2015

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
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 79