MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number TFH-9000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 12/30/2014

Event Type  Injury  

Event Description

Patient with recurrent glioblastoma gbm) began optune therapy on (b)(6) 2014.On (b)(6) 2015, novocure was informed that the patient had been hospitalized due to wound complication from previous resection performed on (b)(6) 2014.On (b)(6) 2015, prescribing physician provided hospital summary.Patient was admitted to the hospital on (b)(6) 2014, due to an infected bone flap.Optune therapy was temporarily discontinued upon hospitalization.On (b)(6) 2015, patient underwent a repeat right frontal craniotomy with removal of the bone flap, wound debridement and placement of a skin graft.Patient received iv antibiotic and wound care.Wound was healing well at the time of the report.Patient was discharged on (b)(6) 2015 and transferred to inpatient rehabilitation for further physical therapy, occupational therapy and completion of a 10-day course of iv antibiotic therapy.At the time of this report, optune therapy was still on hold to allow for wound healing.Per prescribing physician, the event was not related to optune therapy.

Manufacturer Narrative

Novocure concurs with prescribing physician that the event was not related to optune therapy.Contributing factors for the wound complication includes: concomitant bevacizumab (vascular endothelial growth factor inhibitor which carries a black box warning for surgery and wound healing complications including wound dehiscence.Source: bevacizumab prescribing information), concomitant thalidomide (carries a warning for possible wound healing interference.Source: thalidomide prescribing information), concomitant valganciclovir (known adverse reactions include wound dehiscence.Source: valganciclovir prescribing information), prior radiation, chemotherapy and repeat surgery affecting skin integrity.There were no reports of wound infection in the pivotal ef-11 recurrent gbm trial.There have been 5 reports of wound infection in the commercial program to date.

• Brand Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz building, sha'ar hacarmel; 4th floor; haifa ; IS ; 48501204
• MDR Report Key: 4558874
• MDR Text Key: 5550588
• Report Number: 3009453079-2015-00051
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2015

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 Number: TFH-9000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LEVETIRACETAM; ENOXAPARIN SODIUM; CYCLOPHOSPHAMIDE; CELECOXIB; PREDNISONE; BEVACIZUMAB; THALIDOMIDE; VENLAFAXINE; RIVAROXABAN; ALPRAZOLAM; VALGANCICLOVIR; GABAPENTIN ENACARBIL; ONDANSETRON; DIGOXIN
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 48