MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Wound Dehiscence (1154)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Novocure's opinion is that a contribution to the event cannot be excluded.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), prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, chemotherapy and prior surgery affecting skin integrity.Wound dehiscence was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only.

Event Description

A (b)(6) year old female patient with newly diagnosed glioblastoma began optune therapy with concurrent bevacizumab on (b)(6) 2019.On (b)(6) 2019, novocure was informed that the patient developed a fully opened scalp wound with exposed cranium hardware on the surgical resection scar (last resection (b)(6) 2019).On (b)(6) 2019, per prescribing physician confirmed that the patient had not required hospitalization and continued with optune therapy.Wound was treated with hydrocolloid wound dressings and the affected area was avoided during transducer array placement.On (b)(6) 2019, patient reported that on an unspecified date she underwent plastic surgery for the wound.Bevacizumab and optune therapy were temporarily discontinued.Per prescriber, cause of the event was a combination of bevacizumab and optune transducer array placement on a poorly vascularized area on the scalp.

Manufacturer Narrative

On december 23, 2021, novocure discovered that the initial submitted medical device report had a typo in the model number for the optune device in section d4-suspect medical device model number.Corrected model number is tfh9100.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, NH 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 9250496
• MDR Text Key: 177134629
• Report Number: 3009453079-2019-00123
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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: TFH9100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 7 MO
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BEVACIZUMAB.; CLINDAMYCIN.; FUROSEMIDE.; LORAZEPAM.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: White