MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

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

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 12/01/2020

Event Type  Death  

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.

Event Description

N.Huu an, v.Dang luu, m.Duy ton, t.Anh tuan, n.Quang anh, l.Hoang kien, n.Tat thien, d.Viet phuong, n.Minh duc; la clinica terapeutica; 2022; 173 (2):107-114; thrombectomy alone versus bridging therapy in acute ischemic stroke: preliminary results of an experimental trial; doi: 10.7417/ct.2022.2403.Medtronic received information in a literature article of patient¿s potentially treated with a solitaire platinum stent and a react catheter having complications.The purpose of the article was to study the need for intravenous thrombolysis prior to the mechanical thrombectomy (mtb) intervention for patients with acute large vessel occlusion (alvo) in the anterior circulation.From december 2020 to september 2021, 60 patients were recruited in the study and completed the trial.Including 30 assigned to the thrombectomy alone group and 30 assigned to the bridging therapy group.Eligible patients are allocated in pairs to the thrombectomy alone group or the bridging therapy group, with pairs matched according to age (less than 70 years or 70 years or greater), nihss score (less than 14 or 14 and greater) and occlusion site (m1 or other).Immediately following ct or mri to determine eligibility for intravenous thrombolysis (ivt) and mtb, the patients were assigned to one of two treatment groups.All patients were then transferred to the catheterization laboratory without delay to undergo the mtb procedure.Thrombectomy was performed using a second-generation stent retriever, aspiration tubing, a react catheter, or a catheter from a competing manufacturer, or a combined technique at the discretion of the treating physician.Balloon angioplasty and extracranial or intracranial stenting could be performed as rescue therapy in lvo related to atherosclerosis, which required antiplatelets in some cases.The thrombolysis in cerebral infarction (tici) classification was used to grade the initial and final angiograms to evaluate reperfusion out[1]comes.The procedure was completed using an angio-seal 8f (terumo) device or manual compression to accomplish femoral artery closure.From 18 to 30 hours after the intervention, patients were re-evaluated for all clinical and radiological parameters.Clinical assessments included nihss score and hematoma at the site of groin puncture.On day 90, the functional outcome (mrs) was assessed via telephone or at a planned visit.Severe adverse events affecting the final clinical outcome were recorded.During the first passage, the aspiration tubing combined with a stent retriever was the most commonly used technique (64.4%), followed by aspiration tubing alone (23.7%) and the stent retriever alone (11.9%).The median number of passages was 1.Rescue techniques were used in 9 patients (15.3%), including balloon angioplasty alone in 4 cases (6.8%), carotid stenting in 3 cases (5.1%), and intracranial vessel stenting in 2 cases (3.4%).Periprocedural complications occurred in 5 cases (8.5%), including vessel perforation in 4 cases (6.8%) and vessel dissection in 1 case (1.7%).The rate of thrombus migration was significantly lower in the thrombectomy alone group than in the bridging therapy group (0/30 versus 4/30).In the primary analysis, a good clinical outcome (mrs = 2) at 90 days was achieved for 18 of 30 cases (60%) in the thrombectomy alone group and 18 of 30 cases (60%) in the bridging therapy group.The mortality rate at 90-day follow-up was not significantly different, at 3.3% (1/30) in the thrombectomy alone group and 6.7% (2/30) in the bridging therapy group.The proportions of symptomatic intracerebral hemorrhage (ich) did not differ significantly between groups in the post hoc analysis (0% [0/30] in the thrombectomy alone group versus 3.3% [1/30] in the bridging therapy group).Other safety outcomes, such as the ich rate, femoral artery pseudoaneurysm rate, and severe adverse events, were not significantly different between the two groups.

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.

Event Description

Additional information received that in this study, we used solitaire platinum stent and react aspiration catheter for thrombectomy procedure and as we were informed that both of two devices were approved by fda.Of the adverse events that were mentioned within the article, there were not any of them related directly to medtronic devices.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16737787
• MDR Text Key: 313292035
• Report Number: 2029214-2023-00631
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: VM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male