MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Model Number	9735542
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresis (1998); Hydrocephalus (3272)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Blauwblomme t., guida l., beccaria k., bourgeois m., losito e., boddaert n.Laser interstitial thermal therapy for the treatment of deep seated brain tumors and focal epilepsies.Monocentric retrospective study of 23 procedures in 20 children.Child's nerv.Syst.2023 39:5 (1410) https://doi.Org/10.1007/s00381-023-05873-9 abstract objective: laser interstitial thermal therapy has emerged in the last decade as an innovative, successful minimally invasive surgical tool for the ablation of brain lesions.However, it has been available in europe only 3 years ago.Here, we wish to analyze our preliminary results in 23 procedures in 20 children with deeply seated who grade i brain tumors or malformations of cortical development in term of clinical and radiological outcome.Material and methods: monocentric retrospective study of a prospectively acquired database of 20 children consecutively treated with litt in necker hospital.Surgery was performed with the visualase system (medtronic) under mri control, after robotic stereotactic placement of the laser fiber.We reviewed medical files and radiological imaging.Results: 20 children (23 procedures) were operated between february 2021 and december 2022 (m/f ratio=1, mean age 11 yo ;sd 3.9y).Etiologies were as follows: who grade i tumors (n=9), fcd (n=11), hypothalamic hamartoma (n=1).14 children had previous surgery: seeg recording (n=8), stereotactic biopsy (1), incomplete resection (1), litt(2), indirect revascularization for moyamoya (2).Lesion localization was: left insula (7), left mesial temporo occipital (4), left cingulum (n=3), central region (2) basal ganglia/mesencephalon (2), hypothalamus (n=1), left temporal neocortex(1).There were 2 perioperative complications: transient hemiparesis (insular case) and hydrocephalus (midbrain tumor) however no patients had permanent deficits.With a mean follow up of 10.7 months: 13/16 patients were sz free, and tumor relapse was noted in 1/10 case after 6 months.Radiological course depends on histological diagnosis.Conclusion: this preliminary series shows that litt is safe and efficient for children with deeply seated brain lesions both for onc ologic and epilepsy treatments.We highlight in this series specific indications, with scarce available literature, notably in insular epilepsies, and in nf1 patient harboring tumors after cerebral revascularization.Reported events: 2 perioperative complications: transient hemiparesis (insular case) and hydrocephalus (midbrain tumor) however no patients had permanent deficits see attached literature article.
Additional Manufacturer Narrative
A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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.
Additional Manufacturer Narrative
System serial number 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.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.
Event or Problem Description
Additional information was received.It was reported that the adverse events documented in this article are not related to medtronic devices.
Additional Manufacturer Narrative
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: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17352077
• Report Number: 1723170-2023-01284
• Device Sequence Number: 17652742
• Product Code: GEX
• UDI-Device Identifier: 00763000402082
• UDI-Public: 00763000402082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: 9735542
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 09/21/2023; 10/11/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/26/2023; 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male