MAUDE Adverse Event Report: NOVOCURE LTD NOVOTTF-100A

Model Number TFH-9000

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

Patient Problem Ulcer (2274)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Pt with recurrent glioblastoma (gbm) began novottf therapy on (b)(6) 2013.On (b)(6) 2014, novocure was informed that the pt had permanently discontinued novottf therapy due to a scalp ulceration which required surgery.Per hospital summary provided by prescribing physician, pt had presented to the hospital on (b)(6) 2014 with a complex open wound of the left temporal area with exposed cranium, dura and hardware.On (b)(6) 2014, pt underwent excisional debridement of the wound, removal of hardware (exposed plate) and rotation of a large inferiorly based scalp flap to cover the wound and reconstruct the left temple area.Temporary jackson-pratt drain was placed and removed prior to discharge.Wound was noted to be infected per surgery notes (no further info provided).Pt was kept on iv antibiotics and wound was healing well at time of report.Pt was discharged on (b)(6) 2014 on oral antibiotics.

Manufacturer Narrative

Additional serial number #: (b)(4).Prescribing physician and treating surgeon attributed the cause of the skin ulcer to novottf therapy.Novocure medical assessment is that novottf therapy contributed to the skin ulcer.Other contributing factors include: concomitant thalidomide (carries a warning for possible wound healing interference.Source: thalidomide prescribing info), concomitant valganciclovir (known adverse reactions include wound dehiscence.Source: valganciclovir prescribing info), prior radiation, chemotherapy and surgery affecting skin integrity and prior bevacizumab use (bevacizumab is a vascular endothelial growth factor inhibitor which carries a black box warning for surgery and wound healing complications including wound dehiscence.Source: bevacizumab prescribing info).Skin reaction and skin ulcer are known adverse events with use of novottf therapy with an incidence of 16% for device skin reactions and 1% for skin ulcers reported in the pivotal phase iii clinical trial in pts with recurrent gbm.The ifu includes a precaution against placing transducer arrays over areas where craniotomy screws or plates can be felt due to risk for increased skin damage.Prescribers and pts are educated on this during their training.

• Brand Name: NOVOTTF-100A
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg., sha'ar hacarmel; 4th floor; haifa 31905 ; IS 31905 ; 48501204
• MDR Report Key: 3779093
• MDR Text Key: 4445477
• Report Number: 3009453079-2014-00037
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P0100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/24/2014

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?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 50