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 Ischemia Stroke (4418); Insufficient Information (4580)

Event Date 10/19/2021

Event Type  Death  

Event Description

Rhim, j.K., park, j.J., ahn, j.H., kim, h.C., na, d., chai, c.L., <(>&<)> jeon, j.P.(2022).Influence of renal impairment on neurologic outcomes following mechanical thrombectomy in acute vertebrobasilar stroke.Neuroradiology: a journal dedicated to neuroimaging and interventional neuroradiology, 64(4), 807¿815.Https://doi.Org/10.1007/s00234-021-02838-0 medtronic review of the literature article found an analysis of 110 patients who had ischemic stroke caused by vertebrobasilar artery occlusion and underwent mechanical thrombectomy between march 2015 and december 2020 at 4 facilities.Multivariable logistic regression analysis was conducted to assess the associations between renal insufficiency (ri) and outcomes and mortality at 3 months, and the development of intracerebral hemorrhage (ich) after the procedure, as well as the influence of ri on survival probability after patient discharge.It was noted that 49 patients underwent suction thrombectomy, thus it is considered that 61 patients underwent thrombectomy with a solitaire stent retriever.However, there was no specification of which patients were treated with solitaire ab or solitaire fr and there was no specification of the treatment type (suction only vs.Solitaire) in any of the cases, so it could not be known if the patients who had adverse events were treated with a medtronic device or not.There was no device malfunction reported in the article.However, the below adverse patient events were reported: outcome of mortality: - a total of 13 patients had an outcome of mortality within 3 months of treatment.Specific cause of death for each case was not reported in the article.

Manufacturer Narrative

A3.Reported patient sex (male) is representative of the majority of patients included in the literature article study group.A separate report will be submitted for serious adverse patient events without mortality outcome reported in the literature article.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: 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: 17959585
• MDR Text Key: 325973229
• Report Number: 2029214-2023-02038
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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
• Date Manufacturer Received: 10/06/2023
• 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
• Patient Sex: Male