MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-11 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[138354392]
Novocure's medical opinion is that a contribution of the array placement to the event cannot be ruled out. Additional contributing factors for wound dehiscence in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information) and concomitant dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects. Source: (dexamethasone prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity. Wound dehiscence was reported as an adverse event in the (b)(6) trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only.
Patient Sequence No: 1, Text Type: N, H10
[138354393]
A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2017. On (b)(6) 2019, an assistant from the prescriber's office informed novocure that the patient had developed wound dehiscence with exposed ventriculoperitoneal (vp) shunt tubing (most recent surgical resection on (b)(6) 2018). Prior to this report, the patient had been advised by the prescriber to temporarily discontinue optune use to allow the area to heal but the family "adamantly refused" to remove the optune device. A surgical repair with neurosurgery and plastic surgery was planned for an unknown date and optune was discontinued. The patient was on concurrent bevacizumab and steroids at the time of the event. Per the prescribing physician, the cause of the event was bevacizumab, steroids, the patient's medical condition (including poor nutritional intake and low protein), presence of a vp shunt and optune.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2019-00115 |
| MDR Report Key | 8407278 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2019-03-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-03-11 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 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; 2. Required No Informationntervention | 2019-03-11 |