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 07/21/2023

Event Type  Injury  

Event Description

A 47-year-old male patient with newly diagnosed glioblastoma (gbm) started optune therapy on (b)(6) 2022.Novocure was informed on (b)(6) 2023, that the patient was admitted to hospital the same day due to wound dehiscence (last surgical biopsy (b)(6) 2023).Per prescribing physician, last surgical resection was (b)(6) 2023 and current glioblastoma treatment included concomitant lomustine, temozolomide and optune therapy.Per discharge summary provided, patient was admitted on (b)(6) 2023 due to a wound dehiscence measuring approximately 0.5cm at the craniotomy scar site.Exposed hardware was observed, with no signs of purulent discharge.Reportedly, the dehiscence was initially discovered few days prior during routine replacement of transducer arrays.Subsequent surgical intervention took place on (b)(6) 2023, involving wound revision and removal of the exposed hardware.Post-surgical care entailed administering cefuroxime and cefaclor for antibiotic treatment.The patient was discharged on (b)(6) 2023, with sutures in place and no indications of wound irritation.Optune therapy has been temporarily discontinued since (b)(6) 2023.The physician assessed the cause of the event as wound healing disturbance due to steroids and he could not exclude a contribution of optune therapy to the event.

Manufacturer Narrative

Novocure agrees with the prescribing physician that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factors for wound dehiscence in this patient include: concomitant lomustine (carries a black box warning for myelosuppression.Source: lomustine prescribing information), prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease and prior surgeries 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.

• Brand Name: OPTUNE
• Type of Device: OPTUNE
• Manufacturer (Section D): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer (Section G): NOVOCURE GMBH; business village d4; park 6/platz 10; root d4, 6039 ; SZ 6039
• Manufacturer Contact: sharon perez ; 195 commerce way; portsmouth, NH 03801 ; 2077527602
• MDR Report Key: 17554090
• MDR Text Key: 321226651
• Report Number: 3010457505-2023-00244
• Device Sequence Number: 1
• Product Code: NZK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2023

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: TFH9100EU
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2017
• 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: CHOLECALCIFEROL; DEXAMETHASONE; DICLOFENAC SODIUM; DIMENHYDRINATE; ENOXAPARINE SODIUM; LEVETIRACETAM; LOMUSTINE; MACROGOL; METAMIZOLE-SODIUM; METOCLOPRAMIDE; NIRMATRELVIR/RITONAVIR; PANTOPRAZOLE; SODIUM PICOSULFATE; TEMOZOLOMIDE; TRIMETHOPRIM/SULFAMETHOXAZOLE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male