MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-18 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[124166094]
It is unclear if the clinical symptoms in this patient were due to treatment effect (i. E. , radionecrosis), pseudoprogression or true tumor progression. Diagnosis is difficult without a biopsy with histopathology or time. Following radiotherapy, changes on conventional mri including increased perilesional edema and worsened enhancement may represent tumor progression or response to radiation. Approximately 50% of patients will experience imaging changes connoting tumor progression within 1 month of radiation therapy of which 50% are likely to have pseudoprogression rather than progressive disease. Radionecrosis typically is reported within 3-12 months following radiation treatment, with incidence ranging from 5-40% of patients (ellingson et al. , j neurooncol 134 (3): 495-504, 2017). As these events occurred approximately 4 months after the completion of this patient's radiation treatment, they fall within the reported timeframes for either pseudoprogression (3-6 months) or radiation necrosis. Clinical symptoms of acute radiation injury are signs of increased intracranial pressure with progressive focal defects which are typically transient and reversible. Steroids usually alleviate clinical signs and symptoms, as seen in this patient. Novocure opinion is that it is possible that the clinical symptoms were due to a combined treatment effect of radiation plus optune. Radiation necrosis was reported in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the tmz arm of the study only (1%). In the commercial program, there have been (b)(4) prior reports of radiation necrosis, all of which were non-serious and assessed as not related to optune therapy.
Patient Sequence No: 1, Text Type: N, H10
[124166095]
A (b)(6) male patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018. On (b)(6) 2018, the patient's spouse reported that the patient had been hospitalized. Per hospital summary, the patient presented to the hospital on (b)(6) 2018 with worsening confusion, progressive headaches and gait imbalance of 3-4 days duration. Brain mri showed possible disease progression and vasogenic edema. Patient was given 10mg intravenous dexamethasone and admitted to the neuro intensive care unit for monitoring and further assessment. The tumor board concluded the cause of the event was treatment effect rather than recurrence and recommended continuation of dexamethasone plus temozolomide and optune. Patient was discharged home in improved condition on (b)(6) 2018 and started on dexamethasone 4mg bid. At the time of the report, the patient had resumed optune therapy. Per the prescriber, the cause of the events leading to admission was treatment effect, possibly a combination of radiation and optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00108 |
| MDR Report Key | 7979755 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2018-10-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. EILON KIRSON |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31905 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTUNE |
| Generic Name | OPTUNE |
| Product Code | NZK |
| Date Received | 2018-10-18 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE, LTD. |
| Manufacturer Address | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR HAIFA, 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-18 |