MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-19 for OPTUNE TFH91000 N/A manufactured by Novocure, Ltd..
[139176875]
Novocure's medical opinion is that a contribution of the array placement to the event cannot be ruled out. Contributing factors for wound dehiscence and wound infection in this patient also include concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects. Source: dexamethasone prescribing information), concomitant anticoagulants, prior bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications. Source: bevacizumab prescribing information), prior radiation, chemotherapy, and prior surgery affecting skin integrity. Wound infection and wound dehiscence were not reported as adverse events in the (b)(6) trial. In the commercial program, wound infection and wound dehiscence have been reported by <1% of patients to date.
Patient Sequence No: 1, Text Type: N, H10
[139176876]
A (b)(6) female patient with anaplastic astrocytoma began optune therapy on (b)(6) 2018. On (b)(6) 2019, spouse reported that the patient had been hospitalized. Per prescriber, on (b)(6) 2019, patient presented to the emergency room with wound dehiscence exposing the cranial hardware along the right frontal craniotomy site (last craniotomy (b)(6) 2018). Optune therapy and anticoagulant (rivaroxaban) were discontinued upon admission. Blood cultures were positive for coagulase positive staphylococcus. Patient was started on intravenous antibiotic (nafcillin) with recommendation to complete course through (b)(6) 2019, with weekly labs and then transition to oral cephalexin. On (b)(6) 2019, repeat blood cultures were positive for cocci and coagulase positive staphylococcus. Patient underwent wound revision surgery. Postoperatively, patient experienced neurological decline. Repeat head ct showed stable gbm. Steroid medication (dexamethasone) was increased and patient became more alert. Picc line was placed on (b)(6) 2019, after repeat blood cultures were negative. Anticoagulant was restarted on (b)(6) 2019. Patient was discharged on (b)(6) 2019, with instructions to continue with oral antibiotics (cephalexin) and resume optune therapy once surgical incision healed. Per prescriber, the event was unrelated to optune therapy. Patient was noted to have a history of multiple resections and wound revisions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2019-00114 |
| MDR Report Key | 8431819 |
| Report Source | CONSUMER |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-03-01 |
| Device Manufacturer Date | 2017-01-11 |
| Date Added to Maude | 2019-03-19 |
| 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 | 2019-03-19 |
| Model Number | TFH91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 20 MO |
| 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 | 2019-03-19 |