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

Model Number UNK_NAV_SYS

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

Patient Problem Perforation (2001)

Event Date 06/04/2020

Event Type  Death  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.No patient weight was available in the article.Patient death date was not available in the article.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.The unique identifier was not available at the time of reporting.No parts have been received by the manufacturer for evaluation.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Li, c., zhu, h., zong, x., wang, x., gui, s., zhao, p., liu, c., bai, j., cao, l.And zhang, y.Application of endoscopic endonasal approach in skull base surgeries: summary of 1886 cases in a single center for 10 consecutive years.Chinese neurosurgical journal.2020 6:21 1-8.Doi: 10.1186/s41016-020-00199-w background: endonasal endoscopic skull base surgery has undergone rapid technological developments and is now widely performed, but its strengths and weaknesses deserve further investigation and deliberation.This study was performed to investigate the surgical indications, complications, and technical advantages and disadvantages of endonasalendoscopic skull base surgery.Methods: the clinical data of 1886 endoscopic endonasal skull base surgeries performed in our ward at beijing tiantan hospital from june 2006 to june 2016 were retrospectively analyzed.Results: one thousand ninety-three (73.4%, 1490) pituitary adenomas, 54 (24.9%, 217) chordomas, 28 (80.0%, 35) craniopharyngiomas, and 15 (83.3%, 18) meningiomas underwent total resection.Two patients died postoperatively, both having pituitary adenomas.Other postoperative complications included olfactory disorders (n = 226, 11.9%), postoperative cerebrospinal fluid leakage (n = 78, 4.1%), h ypopituitarism (n = 74, 3.9%), diabetes insipidus (n = 64, 3.4%), intracranial infection (n = 36, 1.9%), epistaxis (n = 24, 1.3%), vascular injury (n = 8, 0.4%), optic nerve injury (n = 8, 0.4%), and oculomotor movement impairment (n = 4, 0.2%).In total, 1517 (80.4%) patients were followed up for 6 to 126 months (average, 42.5 months) postoperatively.A total of 196 (13.2%) pituitary adenomas and 13 (37.1%) craniopharyngiomas recurred but no meningiomas recurred.Chordomas recurred in 97 (44.7%) patients, in whom 5-year survival rate was 65%.Conclusion: endoscopic surgery is an innovative surgical technique and the first choice for most midline extradural lesions such as chordomas, and an excellent choice for pituitary adenomas.It probably will be a good technique for many kinds of craniopharyngiomas and a common technique for most of skull base meningiomas, so the surgical indications of these cases should be chosen carefully to make good use of its respective advantages.Reported events: two patients died postoperatively, both were invasive pituitary adenomas.One died of intraoperative carotid artery rupture, and the other died of postoperative intracranial hematoma caused by residual tumor.Olfactory disorders (n = 226, 11.9%) postoperative cerebrospinal fluid leakage (n = 78, 4.1%) hypopituitarism (n = 74, 3.9%) diabetes insipidus (n = 64, 3.4%), intracranial infection (n = 36, 1.9%) epistaxis (n = 24, 1.3%), vascular injury (n = 8, 0.4%), optic nerve injury (n = 8, 0.4%) oculomotor movement impairment (n = 4, 0.2%) 196 (13.2%) with pituitary adenomas and 13 (37.1%) with craniopharyngiomas developed recurrence recurrence of chordomas occurred in 97 (44.7%) patients.

Event Description

Additional information was received stating that the adverse events mentioned in the article has nothing to do with medtronic navigation.More information was refused to be provided.

Manufacturer Narrative

H2) additional information was received.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.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: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11048018
• MDR Text Key: 222789020
• Report Number: 1723170-2020-03360
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death