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

Model Number UNK_VISUALASE_SYS

Device Problems Material Fragmentation (1261); Biocompatibility (2886)

Patient Problems Intracranial Hemorrhage (1891); Paresis (1998); Loss of Vision (2139); Paresthesia (4421); Unspecified Nervous System Problem (4426)

Event Date 05/08/2021

Event Type  Injury  

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.Please note that this date is based off of the date the article was accepted for publication as the event dates were not provided in the published literature.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Malcolm, j.G., miller douglas, j., greven, a., rich, c., dawoud, r.A., hu, r., reisner, a., barrow, d.L., gross, r.E., willie, j.T.Feasibility and morbidity of magnetic resonance imaging-guided stereotactic laser ablation of deep cerebral cavernous malformations: a report of 4 cases.Neurosurgery 0:1¿10, 2021 https://doi.Org/10.1093/neuros/nyab241 background: magnetic resonance imaging (mri)-guided laser interstitial thermal therapy (mrglitt) has been used successfully to treat epileptogenic cortical cerebral cavernous malformations (ccm).It is unclear whether mrglitt would be as feasible or safe for deep ccms objective: to describe our experience with mrglitt for symptomatic deep ccms methods: patients¿ records were reviewed retrospectively.Mrglitt was carried out using a commercially available system in an interventional mri suite with efforts to protect adjacent brain structures.Immediate postoperative imaging was used to judge ablation adequacy.Delayed postoperative mri was used to measure lesion volume changes during follow-up.Results: four patients with ccm in the thalamus, putamen, midbrain, or subthalamus presented with persistent and disabling neurological symptoms.A total of 2 patients presented with disabling headaches and sensory disturbances and 2 with recurrent symptomatic hemorrhages, of which 1 had familial ccm.Patients were considered by vascular neurosurgeons to be poor candidates for open surgery or had refused it.Multiple trajectories were used in most cases.Adverse events included device malfunction with leakage of saline causing transient mass effect in one patient, and asymptomatic tract hemorrhage in another.One patient suffered an expected mild but persistent exacerbation of baseline deficits.All patients showed improvement from a previously aggressive clinical course with lesion volume decreased by 20% to 73% in follow-up.Conclusion: mrglitt is feasible in the treatment of symptomatic deep ccm but may carry a high risk of complications without the benefit of definitive resection.We recommend cautious patient selection, low laser power settings, and conservative temperature monitoring in surrounding brain parenchyma.Reportable events: 1 patient who was 27 years old had a perioperative mild parasthesia.During 1 patients procedure, who was 41 years old, had the device malfunction causing a saline leakage into the brain.Which caused an incomplete ablation, transient upper extremity apraxia and transient left hemiparesis.Also the device top melted due to high laser energy.1 patient who was 14 years old had 2 persistent exacerbation of hemiparesis and hemianopia 1 patient who was 62 years old had a small asymptomatic tract hemorrhage see attached literature article.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12433107
• MDR Text Key: 270271765
• Report Number: 1723170-2021-02210
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2021

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: Health Professional
• Device Model Number: UNK_VISUALASE_SYS
• Device Catalogue Number: UNK_VISUALASE_SYS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 36 YR