MAUDE Adverse Event Report: NOVOCURE LTD NOVOTTF-100A

Model Number TFH-9000

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

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772)

Event Date 07/02/2014

Event Type  Injury  

Event Description

Patient with recurrent glioblastoma receiving bevacizumab q2w, began novottf therapy on (b)(6) 2014.On (b)(6) 2014, the prescribing site informed novocure that the patient had been admitted to the hosp on (b)(6) following fluid leakage at the surgical resection site (latest surgical resection (b)(6) 2014).Novottf therapy was temporarily discontinued.The left occipital cranial wound was oversewn and the patient was observed overnight.On (b)(6), the patient was discharged home.On (b)(6) 2014, the patient was readmitted due to re-leakage at the incision site.Ct scan was negative for hydrocephalus.On (b)(6), patient underwent exploration of the left cranial incision, revision of the dural graft, placement of a new duraguard graft to seal a cerebrospinal fluid (csf) leakage and placement of a ventriculostomy into the occipital horn for diversion of csr.Prophylactic i.V.Vancomycin was initiated.On (b)(6), patient noted headache and neck ache.At the time of the report, the patient was still hospitalized and had not yet restarted novottf therapy.Per the prescribing physician, the events were not related to novottf therapy.

Manufacturer Narrative

Novocure concurs with the prescribing physician that the events were not related to novottf therapy.Contributing factor for wound dehiscence and csf leakage in this patient include prior radiation, chemotherapy, multiple craniotomies (most recent resection (b)(6) 2014; 3 resections total) and 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 info).There were no reports of would dehiscence in the pivotal ef-11 recurrent gbm trial.There have been (b)(4) reports of wound dehiscence/wound complication in the commercial program to date.There was (b)(4) report of a csf leakage in the novottf therapy arm of the pivotal ef-11 recurrent gbm trial.

• Brand Name: NOVOTTF-100A
• Manufacturer (Section D): NOVOCURE LTD; haifa ; IS
• Manufacturer Contact: eilon kirson ; topaz bldg. sha'ar hacarmel; 4th floor; haifa ; IS ; 4850124
• MDR Report Key: 4058867
• MDR Text Key: 4811068
• Report Number: 3009453079-2014-00042
• 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: 08/05/2014

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: 08/05/2014
• Initial Date FDA Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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: DOCUSATE SODIUM; LEVETIRACETAM; ONDANSETRON; GABAPENTIN; BEVACIZUMAB; CITALOPRAM; FAMOTIDINE
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 98