MAUDE Adverse Event Report: NOVOCURE GMBH OPTUNE

Model Number TFH9100

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

Patient Problem Hydrocephalus (3272)

Event Date 08/29/2020

Event Type  Injury  

Manufacturer Narrative

Novocure medical opinion is that the event is unrelated to ttfields use.Optune meets the iec 60601-1 standards for electromagnetic compatibility (emc) compliance.It is known to emit energy at the treatment frequency (in this case, 200khz) which is allowable under the standard (see attached pma p100034 pp.14-16 for emc testing verification/validation information).If a sensitive piece of electronic equipment is not properly shielded against such frequencies it could exhibit abnormal behavior.Use of active electronic devices including programmable shunts is listed as a contraindication in the optune instructions for use.Per the ifu, use of optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device.Literature review has shown one published case study (chan et al., cureus, 2016 jul; 8(7):e675) which demonstrated that optune did not have any effect on the stability of programmable shunt valve settings in a gbm patient undergoing treatment with optune.Optune does not contain magnetic elements required to modify shunt valve settings of the hakim valve.As the valve system works with a mechanical mechanism electronic interference is not likely.In addition, according to available poster, hydrocephalus continued even after optune discontinuation and valve re-setting, requiring shunt removal surgery.This indicates that the shunt malfunction continued even after optune discontinuation and valve re-adjustment.Vp shunt complications have been reported in the literature as occurring in 11.8% of patients with brain tumors, with 6.7% of patients requiring shunt removal (source: nigim et al, oncology, 2015, 3:1381-1386).Hydrocephalus is an expected event with device use and 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 both arms of the trial (1% and 1% in optune/tmz and tmz arms respectively).Hydrocephalus is an expected complication of gbm with a reported incidence of 7.28% (fischer et al., clin neuro & neurosurg, 2014: 27-31).

Event Description

During the european association of neurosurgical societies 2021 conference, novocure became aware of a reported case of potential medical device interference with a ventriculoperitoneal (vp) programmable shunt.Novocure investigated the case by contacting the first author of the scientific poster.A (b)(6)-year-old male patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2020, with vp programmable shunt in place (implantation date: (b)(6) 2019).According to available medical records, patient required vp shunt removal surgery in (b)(6) 2020, due to gastrointestinal issues and an external ventricular drain (evd) was placed.On (b)(6) 2020, a programmable ventriculo-arterial (va) shunt was implanted (hakim valve, without anterior chamber, integra).Optune therapy was temporarily discontinued between (b)(6) 2020, and (b)(6) 2020.According to the first author's response, the valve settings were monitored both on (b)(6), and (b)(6) 2020.In the radiographs of both days, the valve opening pressure level was unchanged at 120 mm h2o, until the onset of clinical deterioration on (b)(6) 2020.Per conference poster, valve settings were suspected to have changed during the night of (b)(6) to (b)(6) 2020, which resulted in cerebrospinal fluid (csf) underdrainage.The valve setting was adjusted under fluoroscopy, however hydrocephalus persisted.The malfunctioning va shunt was removed and a new vp shunt (type unknown) was placed on (b)(6) 2020.Patient's optune device logfile review did not reveal any device errors during the reported time frame of valve misalignment between (b)(6)-(b)(6) 2020.Optune was temporarily discontinued between (b)(6)-(b)(6) 2020.Patient resumed optune therapy on (b)(6) 2020, without further complications reported.Optune therapy was permanently discontinued on (b)(6) 2021, due to tumor progression.The author did not provide information regarding whether the vp shunt malfunction continued after optune discontinuation, nor provided information on re-challenge.The valve system was reportedly checked.There was no outflow at 12 cm above meatus acusticus externus, but there was h2o at about 18-20 cm.Therefore, for the physicians it was reasonable to assume that the shunt valve had misaligned from (b)(6)-(b)(6).Per author, the only external influence was ttfields therapy.

• 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: 12978399
• MDR Text Key: 285744106
• Report Number: 3010457505-2021-00190
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2021

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: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• 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: BIBROCATHOL 2% EYE OINTMENT; BUPRENORPHINE; DEXAMETHASONE; EDOXABAN; ERGOCALCIFEROL; LEVETIRACETAM; LEVOFLOXACIN; METAMIZOLE; OFLOXACIN EYE DROPS; PANTOPRAZOLE; PIPERACILLIN; POTASSIUM POWDER; SPIRONOLACTONE; TAZOBACTAM; TOLPERISONE; TORASEMIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male