MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

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

Patient Problems Intracranial Hemorrhage (1891); Vasoconstriction (2126); Perforation of Vessels (2135); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Insufficient Information (4580)

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

Chen z, liu y, li b, et al.Comparing the conventional and balloon-guided catheter-assisted swim technology for the treatment of acute ischemic stroke.Frontiers in neurology.2022;13:866673.Doi: 10.3389/fneur.2022.866673.Event date: please note that this date is based off of the date of publication 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

Chen z, liu y, li b, et al.Comparing the conventional and balloon-guided catheter-assisted swim technology for the treatment of acute ischemic stroke.Frontiers in neurology.2022;13:866673.Doi:10.3389/fneur.2022.866673.Medtronic literature review found a report of patient complications in association with the solitaire stent, navien catheter, and rebar microcatheter.The purpose of this article was to explore whether using the balloon-guided catheter (bgc) would improve the effect of stent thrombectomy (solitaire fr with intracranial support catheter for mechanical thrombectomy, swim) for patients with acute ischemic stroke due to large vessel occlusion (ais-lvo).The data of 209 patients with ais-lvo underwent swim were collected retrospectively from january 2017 to june 2021.These patients were divided into two groups based on whether they used of bgc or not.The propensity score matching (psm) analysis was used to compare the differences in the first pass effect (fpe), successful recanalization, embolus escape rate, symptomatic intracranial hemorrhage (sich), 90-day clinical favorable outcome, 90-day all-cause mortality, and complications in the patients treated with swim combined with balloon-guided catheter or conventional catheter.Among the 209 patients, 44 patients were treated with bgc and 165 patients were not.After matching, a total of 111 patients were included.For the procedures, an 8f bgc (fg2 or merci) or 8f conventional catheter (neuromax) was positioned at the extracranial segment of the occluded ica, then, an intracranial support catheter (navien) was introduced, and a microcatheter (rebar 18 or 27) was placed over the microwire (transend-platinum) of the occluded area.Under the road map, the stent (solitaire ab) was advanced to the occluded segment and withdrew the microcatheter to deploy the stent for 5 min.Subsequently, the stent was partially retrieved by microcatheter and pushed the intracranial support catheter (navien) to the proximal end of the stent.The stent, microcatheter, and intracranial support catheter were gently pulled back to the guide catheter as a unit.In the bgc group, before stent retrieval, the balloon of the bgc was inflated to arrest the antegrade ica flow.After the stent was retrieved, the balloon was immediately deflated to allow ica re-circulation.Follow-up angiography was conducted immediately.If blood flow returned to modified thrombolysis in cerebral infarction (mtici) =2b and could still maintain mtici =2b after 15 min, the procedure was ended.However, if retrieval failed or recanalization was insufficient (mtici <(><<)>2b), the procedure would be repeated, but the total number of thrombectomy was not more than 4 times.If the target segment stenosis was >70% or cannot maintain blood flow, rescue therapy, such as balloon angioplasty or stent implantation, would be carried out the article does not state any technical issues during use of the solitaire, navien, or rebar catheters the following intra- or post-procedural outcomes were noted: - 21 cases of 90-day all-cause mortality  -11 patients had symptomatic intracranial hemorrhage (sich)  -procedural complications were defined as target vessel perforation, dissection, or spasm and occurred in 7 cases -no significant difference was found in embolus escape rate, there were 8 cases total -there were 35 patients that achieved fpe, about 35.1%  in the non-bgc group compared to 24.3% in the bgc group -the rate of successful recanalization did not differ between the two groups; 100 patients had successful recanalization -90-day favorable outcome (defined as 90-day mrs 0 to 2) was achieved in 58 cases.

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.

Event Description

Additional information received.The adverse events were not related to medtronic products.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 16479415
• MDR Text Key: 310728914
• Report Number: 2029214-2023-00400
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• 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,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• 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