MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7; INSTRUMENT, STEREOTAXIC

Model Number 9733858

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Edema (1820); Facial Nerve Paralysis (1846)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender was 19 males and 19 females.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: tomasz szmuda, pawel sloniewski, shan ali, pedro m.Goncalves pereira, mateusz pacholski, fanar timemy, agnieszka sabisz, edyta szurowska, sara kieronska.Reliability of diffusion tensor tractography of facial nerve in cerebello-pontine angle tumours.Polish journal of neurology and neurosurgery.Doi: 10.5603/pjnns.A2020.0001 abstract: aim of the study: this study aimed to verify the accuracy of preoperative visualisation of the facial nerve (fn) by magnetic resonance-based (mr) diffusion tensor imaging-fibre tracking (dti-ft) with neuronavigation system integration in patients with cerebello-pontine angle (cpa) tumours.Clinical rationale for the study: complete excision with preservation of the fn remains the critical goal of today¿s vestibular schwannoma (vs) surgery.Dti-ft of the fn with neuronavigation is yet to be fully evaluated, and could make surgery safer.Materials and methods: this was a prospective cohort study in which 38 consecutive patients with a cpa tumour (32 vss, five meningiomas and one epidermoid cyst) were operated on via the retrosigmoid route from 2013 to 2019.The course of the fn was simulated before surgery using stealthviz and the images were transferred to the medtronic s7 neuronavigation system.The fn location reconstructed by dti-ft was verified during the surgery.Results.Mr acquisition was inappropriate in three patients (7.9%).Dti-ft correctly predicted the course of the fn in 31 of the 38 patients; the discordance rate was 18.4%.The accuracy of dti-ft was 81.6% (95% ci: 65.67-92.26), sensitivity 88.57% (95% ci: 73.26-96.80) and positive predictive value was 91.18% (95% ci: 90.17-92.09).The reliability of the neuronavigation-integrated visualisation of the fn did not depend on the tumour size (p = 0.85), but the method was more accurate when the nerve was compact in shape (p = 0.03, area under curve (auc) 0.87, 95% ci: 0.60-1.00) and in females (p = 0.04, auc 0.78, 95% ci: 0.56-1.00).Following surgery, 86.5% of the patients presented with useful facial function (house-brackmann grades i-iii).Correct simulation of the fn did not prevent postoperative facial palsy (p = 0.35).Conclusions.The accuracy of dti-ft of the fn integrated with neuronavigation remains unsatisfactory.This method does not provide any clinical benefit over non-integrated dti-ft in terms of nerve function preservation.Clinical implications.Due to the low reliability of the predictions, further technical advances inpredicting the course of the fn are awaited by clinicians.However, dti-ft images in the operating theatre would make tumour excision more comfortable for the surgeon.Reported events: 14 patients experienced a surgery-related facial palsy.4 patients experienced post-operative cerebrospinal fluid (csf) leakage, which was treated successfully by external lumbar drainage.

Manufacturer Narrative

H2) correction: patient coding updated from c3002 to c26769.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10672834
• MDR Text Key: 215886552
• Report Number: 1723170-2020-02697
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR