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U.S. Department of Health and Human Services

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

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NOVOCURE LTD. OPTUNE; OPTUNE, PRODUCT CODE: NZK Back to Search Results
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.
 
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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 Key5263592
MDR Text Key32594348
Report Number3009453079-2015-00066
Device Sequence Number1
Product Code NZK
UDI-Device Identifier07290107980401
UDI-Public07290107980401
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100034
Number of Events Reported1
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 NumberTFH-9000
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age3 YR
Initial Date Manufacturer Received 11/12/2015
Initial Date FDA Received12/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
DEXAMETHASONE
Patient Outcome(s) Hospitalization;
Patient Age50 YR
Patient Weight79
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