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 Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)

Event Date 04/21/2022

Event Type  Injury  

Event Description

Kitamura t, koyanagi m, ogura t, chihara h, miyata t, hatano t.Impact of the position of the aspiration catheter to the first pass effect during the combined technique.Clinical neurology and neurosurgery.2022;217.Doi:10.1016/j.Clineuro.2022.107257 medtronic literature review found a report of patient complications in association with the react71 catheter.The purpose of this article was to evaluate whether the rate of the first pass effect improved when capturing the proximal end of the thrombus by aspiration catheter (captac) was achieved in mechanical thrombectomy using combined techniques.A prospectively-maintained acute stroke database at was searched for patients who underwent mechanical thrombectomy (mt) at the researchers hospital between january 2017 and december 2020.Medical and radiological records of the patients were retrieved and retrospectively reviewed.Eighty-one patients were identified.Balloon-guiding catheter (bgc) was used in all patients.In this study, 42 of 81 patients achieved capturing the proximal end of the thrombus by aspiration catheter (captac) during the procedure.  all procedures were performed under local anesthesia.A 9fr bgc (optimo) was placed into the internal carotid artery.Aspiration catheter was selected from the penumbra ace60, penumbra ace68, react71, or the catalyst6.Cases were divided into two groups according to the periods of the procedure.Up until november 2019 (period 1), the penumbra ace60 and the penumbra ace68 were used, while after november 2019, the react71 or the catalyst6 (period 2) were used.A larger pore-size aspiration catheter (penumbra ace68 or react71) was selected for proximal m1 segment occlusion, while a smaller pore-size aspiration catheter (penumbra ace60 or catalyst6) was used for distal m1 or m2 segment occlusion.A coaxial configuration of aspiration catheter, microcatheter, and microguidewire was advanced into the intracranial internal carotid artery.Before the microcatheter was advanced beyond the thrombus, inflation of the bgc balloon and continuous aspiration using the aspiration pump from the aspiration catheter were initiated to prevent distal migration of the thrombus.After the microcatheter was advanced across the occlusion, the stent retriever of choice was deployed.The type of stent retriever was selected at the discretion of the operator.The microcatheter was then removed after deployment of the stent retriever to improve aspiration performance.  next, the aspiration catheter was advanced to contact the proximal edge of the thrombus using the stent retriever as an anchor.  the article does not state any technical issues during use of the react71 catheter.The following intra- or post-procedural outcomes were noted: -final successful reperfusion rates were similar between the two groups.Modified thrombolysis in cerebral infarction; mtici score was 2b/3 in 65 patients out of 81 -there were no differences in hemorrhagic complications or mrs score at 90 days between the two groups; 5 patients in the group using the react-71 catheter had subarachnoid hemorrhage, 6 had intracranial hemorrhage, and 1 had symptomatic hemorrhage -there was a trend towards more frequent asymptomatic ich in the newer generation devices group.However, there was no difference in the mrs score at 90 days between the two groups.  -29 patients had mrs score of 0-2 at 90 days -45 patient had mrs score of 0-3 at 90 days.

Manufacturer Narrative

Kitamura t, koyanagi m, ogura t, chihara h, miyata t, hatano t.Impact of the position of the aspiration catheter to the first pass effect during the combined technique.Clinical neurology and neurosurgery.2022;217.Doi:10.1016/j.Clineuro.2022.107257 b.3.Please note that this date is based off of the date the article was available online 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.

• 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: 16791608
• MDR Text Key: 313800916
• Report Number: 2029214-2023-00678
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182097
• 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: 04/21/2023

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: 04/21/2023
• 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): Other