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 Code	Post Operative Wound Infection (2446)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
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.G4) 510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Sanvito, f., telesca, d., cho, n.S., sayari, j.T., nagaraj, r., raymond, c., rana, s., patel, k., mozaffari, k., unterberger, a.A., khanlou, n., magaki, s., pouratian, n., everson, r.G., yang, i., kim, w., ellingson, b.M.Small pretreatment lesion size and high sphericity as favorable prognostic factors after laser interstitial thermal therapy in brain metastases.J neurosurg.2024.140:338¿349.Doi: 10.3171/2023.5.Jns23285.Objective the objective of this study was to identify baseline clinical and radiological characteristics of brain metastases (bms) associated with a higher probability of lesion-specific progression-free survival (pfs-l) after laser interstitial thermal therapy (litt).Methods a total of 47 lesions in 42 patients with bms treated with litt were retrospectively examined, including newly diagnosed bm, suspected recurrent bm, and suspected radiation necrosis.The association of baseline clinical and radiological features with pfs-l was assessed using survival analyses.Radiological features included lesion size measurements, diffusion and perfusion metrics, and sphericity, which is a radiomic feature ranging from 1 (perfect sphere) to 0.Results the probability of pfs-l for the entire cohort was 88.0% at 3 months, 70.6% at 6 months, 67.4% at 1 and 2 years, and 62.2% at 3 years.For lesions progressing after litt (n = 13), the median time to progression was 3.9 months, and most lesions (n = 11) progressed within 6 months after litt.In lesions showing response to litt (n = 17), the median time to response was 12.1 months.All 3 newly diagnosed bms showed a long-term response.The mean (± sd) follow-up duration for all censored lesions (n = 34) was 20.7 ± 19.4 months (range 12 days to 6.1 years).The mean pretreatment enhancing volume was 2.68 cm3 and the mean sphericity was 0.70.Pretreatment small enhancing volume (p = 0.003) and high sphericity (p = 0.024) computed from lesion segmentation predicted a longer pfs-l after litt.Lesions meeting optimal cutoffs of either enhancing volume <(><<)> 2.5 cm3 (adjusted p = 0.004) or sphericity = 0.705 (adjusted p = 0.019) had longer pfs-l, and their probability of pfs-l was 86.8% at 3 years.Lesions meeting both cutoffs showed a cum ulative benefit (p <(><<)> 0.0001), with a 100% probability of pfs-l at 3 years, which was unchanged at the end of followup (4.1 years).Manually computed estimates of lesion size (maximal axial diameter, p = 0.011) and sphericity (p = 0.043) were also predictors of pfs-l.Optimal cutoffs of diameter <(><<)> 2 cm (adjusted p = 0.035) or manual sphericity = 0.91 (adjusted p = 0.092) identified lesions with longer pfs-l, and lesions meeting both cutoffs showed a cumulative benefit (p = 0.0023).Baseline diffusion imaging did not predict pfs-l.A subset of lesions (n = 7) with highly perfused hotspots had worse pfs-l (adjusted p = 0.010), but perfusion signal contamination from vessels and cortex and underlying size differences were possible confounders.Conclusions small size and high sphericity are ideal baseline features for lesions considered for litt treatment, with a cumulative pfs-l benefit when both features are present, that could aid patient selection.Reported events: two patients experienced complications linked to pin site infection, both successfully managed using oral antibiotics.
Event or Problem Description
Additional information was received.One patient had pin site infection with intracranial involvement, related to the burr hole access, which was conservatively treated using oral antibiotics, with success.One patient had a superficial erythema and drainage, extracranial, related to the burr hole access, which was conservatively treated using oral antibiotics, with success.One patient had a mild worsening of pre-existing visual disturbances, which was possibly linked to the fiber placement and the laser treatment.One patient had a mild worsening of pre-existing gait disturbances, which was possibly linked to the fiber placement and the laser treatment.One patient had a slight reduction in the sensation of the thigh (mild hypoesthesia), which was possibly linked to the fiber placement and the laser treatment.
Additional Manufacturer Narrative
Additional information in a4, b5, d1, and d4.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20126269
• Report Number: 1723170-2024-02471
• Device Sequence Number: 7417790
• Product Code: GEX
• UDI-Device Identifier: 00643169655935
• UDI-Public: 00643169655935
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2016
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 77 KG