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

Model Number UNK-NV-SFR

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

Patient Problem Insufficient Information (4580)

Event Date 11/10/2016

Event Type  Death  

Event Description

Gurkas e, akpinar ck, aytac e.Advance: an effective and feasible technique in acute stroke treatment.Interventional neuroradiology.2017;23(2):166-172.Doi:10.1177/1591019916682358.Medtronic literature review found a report of patient complications in association with a solitaire fr stent retriever, navien intracranial support catheter, and rebar microcatheter.The purpose of this article was to describe a novel technique named advance that is based on advancing a distal access catheter over the stent, and to report the initial results with this novel thrombectomy technique.Sixty-seven acute anterior circulation ischemic stroke patients (35 male, 32 female; mean age 61 years) who were treated by mechanical thrombectomy were included.Patients were classified randomly into two groups: patients treated with either the advance technique or standard technique.Procedures used either a solitaire fr or preset phenox (b)(4) stent retriever, and navien and rebar catheters.There were no advance technique-related complications.The article does not state any technical issues during use of the solitaire, navien, or rebar.The following intra- or post-procedural outcomes were noted:  - 9 patients died (mrs=6) within 90-days of the procedure (5 with standard technique, 4 with advance technique).

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: SOLITAIRE FR
• 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: 16433286
• MDR Text Key: 310127294
• Report Number: 2029214-2023-00354
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

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-SFR
• Device Catalogue Number: UNK-NV-SFR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 02/23/2023
• 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