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 07/24/2014

Event Type  Injury  

Event Description

Pt with recurrent glioblastoma began novottf therapy on (b)(6) 2014.On approximately (b)(6) 2014, while on novottf therapy plus bevacizumab, the pt developed a skin ulcer at the site of the prior resection scar (most recent tumor resection on (b)(6) 2014).The site required wound debridement and closure and subsequently healed.On an unk date, pt developed another ulcer on the scalp also at the resection scar.On (b)(6) 2014, pt was admitted to the hosp overnight for wound debridement and closure.Novottf therapy was held for 10 days to allow incision to heal and was restarted on (b)(6) 2014.On (b)(6) 2014, novottf therapy was temporarily discontinued due to wound healing issues.On (b)(6) 2014, pt was again hospitalized to reclose the wound.There was no report of injection associated with the wound.On (b)(6) 2014 pt was discharged.At the time of this report, novottf therapy was still being held to allow for wound healing.

Manufacturer Narrative

Novocure med opinion is that novottf therapy contributed to the skin ulcer.Contributing factors for skin ulcer in this pt include concomitant bevacizumab (vegf inhibitor which carries a black box warning for surgery and wound healing complications including wound dehiscence.Source: bevacizumab prescribing info), prior radiation, chemotherapy and multiple surgeries affecting skin integrity.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 the risk for increased skin damage.Prescribers and pt 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; fourth floor; haifa 31905 ; IS 31905 ; 48501204
• MDR Report Key: 4135674
• MDR Text Key: 4950865
• Report Number: 3009453079-2014-00044
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 09/10/2014

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: 09/10/2014
• Initial Date FDA Received: 09/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: 68 YR
• Patient Weight: 62