MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS

Model Number REACT-71

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Vasoconstriction (2126); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438)

Event Date 05/08/2022

Event Type  Injury  

Manufacturer Narrative

Amuluru k, nguyen j, al-mufti f, et al.Safety and effectiveness of mechanical thrombectomy for acute ischemic stroke using single plane angiography.Journal of stroke and cerebrovascular diseases¿: the official journal of national stroke association.2022;31(8):106553.Doi:10.1016/j.Jstrokecerebrovasdis.2022.106553.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of acceptance of the article as the event dates were not provided in the published literature.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

Amuluru k, nguyen j, al-mufti f, et al.Safety and effectiveness of mechanical thrombectomy for acute ischemic stroke using single plane angiography.Journal of stroke and cerebrovascular diseases: the official journal of national stroke association.2022;31(8):106553.Doi:10.1016/j.Jstrokecerebrovasdis.2022.106553 medtronic literature review found a report of patient complications in association with the solitaire platinum and react-71.The purpose of this article was to compare the safety and effectiveness of mechanical thrombectomy performed on single-plane (sp) vs.Biplane (bp) systems.  this retrospective case control study included consecutive patients with emergent large vessel occlusion (elvo) treated with mechanical thrombectomy between 7/1/2020 and 7/29/2021 at a single high-volume practice.Patients were dichotomized based on treatment with either single plane (sp) or biplane (bp) system use.Patients were excluded if primary outcome follow-up data was unavailable.246 patients with ais due to elvo were treated with mechanical thrombectomy, of which 35 patients were excluded due to incomplete follow-up clinical outcome data.Of the 211 patients included and treated with mechanical thrombectomy, 70 and 141 were treated on sp and bp systems, respectively.There were 117 males and 94 females with a median age of 67 and 69 for the sp and bp groups respectively.A significant difference in the prevalence of hyperlipidemia existed between the patients treated with sp and bp, thus outcomes were adjusted for hyperlipidemia status in multivariate analysis.Otherwise, baseline characteristics did not differ significantly regarding demographics, clinical presentation, or thrombus location all procedures were performed under general anesthesia and thrombectomies were performed using either a combination stentriever (solitaire platinum or embotrap ii) through an aspiration catheter; sofia 5f or 6f; react 71; penumbra red, or a direct aspiration technique according to the operator¿s discretion.Intracranial thrombectomy was determined to be successful if the resulting therapy resulted in tici 2b-3 recanalization.In cases of tandem occlusions, adjunctive procedures including balloon angioplasty and carotid stenting were performed at the operator¿s discretion.Adjunctive intraarterial thrombolytics were not used.The article does not state any technical issues during use of the solitaire platinum or react-71 the following intra- or post-procedural outcomes were noted: -26 patients had recanalization failure -patients experienced similar rates of peri-procedural complications comparing sp and bp systems; 78 patients had peri-procedural co mplications (periprocedural complications included embolization to new territory, intra- and peri-procedural hemorrhage, early reperfusion hemorrhage, late infarct transformation, subarachnoid hemorrhage, vasospasm, vessel re-occlusion, and vessel perforation.) -patients experienced similar rates of intra-procedural vascular injury (dissection/laceration comparing sp and bp systems; 5 patients had vessel perforation and 0 vessel dissections -there was no significant difference in follow-up functional status at 2-5 months post-procedure, with ¿good outcome¿ defined as mrs less than or equal to 2.114 patients had poor outcomes (mrs greater than or equal to 3) - 27 patients had additional treatment.

• Brand Name: REACT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 16735237
• MDR Text Key: 313303058
• Report Number: 2029214-2023-00626
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2023

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: REACT-71
• Device Catalogue Number: REACT-71
• 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
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male