MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-02-26 for OPTUNE TFH-9100 N/A manufactured by Novocure Ltd.
[100905903]
Novocure medical opinion is that contribution of the array placement to the event cannot be ruled out. 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). Wound infection is an expected event with device use and 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 both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively). Wound dehiscence was reported as an adverse event in the (b)(6) trial in the optune/tmz arm of the trial (<1%) only. Osteomyelitis was not reported as an adverse event in the (b)(6) trial. There have been 3 prior reports of osteomyelitis in the commercial program to date.
Patient Sequence No: 1, Text Type: N, H10
[100905904]
A (b)(6) male patient with newly diagnosed glioblastoma began optune with concurrent bevacizumab on (b)(6) 2016. On (b)(6) 2018, the spouse observed pus and blood at the craniotomy resection scar site. Patient temporarily discontinued optune therapy. On (b)(6) 2018, patient was hospitalized and scheduled for wound revision surgery (last tumor resection (b)(6) 2017) which was subsequently cancelled for unknown reason. On (b)(6) 2018, the prescribing physician reported that the patient was experiencing wound dehiscence with wound infection and osteomyelitis and was being treated with antibiotics. On (b)(6) 2018, spouse reported patient was hospitalized and scheduled for surgery. On (b)(6) 2018, the patient underwent a wound debridement and bone flap excision. Per the prescribing physician, optune therapy probably contributed to the wound dehiscence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00092 |
| MDR Report Key | 7295817 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-01-03 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2014-02-03 |
| Date Added to Maude | 2018-02-26 |
| 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, IL 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE LTD |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, IL 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 | 2018-02-26 |
| Model Number | TFH-9100 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 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, IL 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-26 |