MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number UNK-NV-SAB

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 06/01/2011

Event Type  Death  

Event Description

The purpose of this study was to assess the safety and efficacy, and to investigate the predictors for good and poor outcomes of thrombectomy for treatment of ais due to anterior circulation large vessel occlusions (lvos) in brazil.This was a single center registry of thrombectomy in the treatment of stroke caused by anterior circulation lvos.Between 2011 and 2019, a total of 565 patients were included, 297 male and 268 female, average age was 66.9 years.The mean baseline nihss score on admission was 17.2.The average baseline aspects was 8, and 91.0% of patients scored greater than or equal to 6.Half of the patients received intravenous thrombolysis.The mean time from symptom onset to arterial puncture was 296.4 minutes.The mean procedure time was 61.4 minutes.The rates of the main outcomes were recanalization (tici 2b-3) 85.6%, symptomatic intracranial hemorrhage (sich) 8,1%, good clinical outcome (mrs¼0-2) 43.5%, and mortality 22.1% at three months.This study demonstrates the efficacy and safety of mechanical thrombectomy for tr eatment of patients with ais of the anterior circulation in real-life conditions under limited facilities and resources.The results of the present study were relatively similar to those of large trials and population registers of developed countries.  the article does not state any technical issues during use of the solitaire ab, solitaire fr, solitaire platinum and cello 8f/9f devices.

Manufacturer Narrative

Fornazari vr, de castro-afonso lh, nakiri gs, abud tg, monsignore lm, dias fa, pontes-neto om, and abud dg.Analysis of 565 thrombectomies for anterior circulation stroke: a brazilian registry.Interventional neuroradiology.2022, vol.28(3) 283-290.Doi: 10.1177/ 15919199211026995.Average age of participants in the article was 66.9 years.565 patients were included, 297 male and 268 female.Male in a3 represents the majority.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 AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 16053463
• MDR Text Key: 306192879
• Report Number: 2029214-2022-02185
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SAB
• Device Catalogue Number: UNK-NV-SAB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• 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): Other; Death
• Patient Age: 67 YR
• Patient Sex: Male