MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 01/01/2019

Event Type  Death  

Event Description

Qiu k, zhao lb, xu xq, wang y, liu j, shi hb, zu qq.Acute embolic stroke with large-vessel occlusion: does contact aspiration thrombectomy show superiority? clinical radiology (2022), 577-583.Doi: https://doi.Org/10.1016/j.Crad.2022.05.020.The purpose of this article was to compare the efficacy between contact aspiration thrombectomy and stent retriever thrombectomy in the treatment of acute embolic stroke patients with large vessel occlusion.  between january 2019 and june 2020, data from consecutive acute ischemic stroke patients who underwent either endovascular contact aspiration or stent retriever thrombectomy were analyzed at one institution.The primary outcome was the full 90-day modified rankin scale (mrs) score.Ordinal logistic regression analysis was used to assess the association between thrombectomy approach and functional outcomes.A total of 156 patients were analyzed.83 were female, 73 were male, the average age was 70.7 years.Among them, 57 (36.5%) patients underwent primary aspiration thrombectomy, while 99 (63.5%) patients underwent primary stent retriever thrombectomy.The median procedure time was significantly shorter in patients treated with aspiration (37 versus 56 minutes; compared with those of patients who underwent stent retriever thrombectomy, successful recanalization rates and favorable functional outcome rates were higher in patients who underwent the aspiration approach.Ordinal logistic regression analysis showed that aspiration thrombectomy was independently associated with a good functional outcome.  in total, 55 (35.3%) patients achieved functional independence at the 90-day follow-up.The proportion of functional independence was higher among patients with aspiration than among patients with stent retrievers.The all cause 90-day mortality rate was 26.9% (42/156).No significant relation existed between 90-day mortality rates and thrombectomy approach.The article does not state any technical issues during use of the solitaire ab, navien, or rebar.The following intra- or post-procedural outcomes were noted: 1.Emboli in new territory 2.Symptomatic intracranial hemorrhage 3.Mortality.

Manufacturer Narrative

Qiu k, zhao lb, xu xq, wang y, liu j, shi hb, zu qq.Acute embolic stroke with large-vessel occlusion: does contact aspiration thrombectomy show superiority? clinical radiology (2022), 577-583.Doi: https://doi.Org/10.1016/j.Crad.2022.05.020.Age represents the average age of the participants.Sex female represents the majority of the participants.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: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15695198
• MDR Text Key: 302671017
• Report Number: 2029214-2022-01827
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• 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: 09/29/2022
• 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): Death
• Patient Age: 71 YR
• Patient Sex: Female