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 Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 03/14/2023

Event Type  Death  

Manufacturer Narrative

G2: citation: authors: serhan yildirim.Predictors of good clinical outcome in acute ischemic stroke patients after mechanical thrombectomy.Turkish journal of cerebrovascular diseases 1 2023.Doi: 10.5505/tbdhd.2023.03779 a.2.This value is the median age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Earliest date of acceptance used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Yildirim, s.Predictors of good clinical outcome in acute ischemic stroke patients after mechanical thrombectomy.Turkish journal of cerebrovascular diseases 2023, 29(1), 28-37.Doi: 10.5505/tbdhd.2023.03779 medtronic literature review found a report of patient complications in association with the navien and rebar catheter.The purpose of this article was to identify the predictors of good clinical outcome in acute stroke patients treated with mechanical thrombectomy (mt).This study was designed retrospectively.Acute ischemic stroke patients treated with mechanical thrombectomy because of the internal carotid artery or m1 segment of the middle cerebral artery occlusion between 2018 and 2022 were included in this study.Mrs score =2 on the 90th day was defined as a good clinical outcome.A total of 110 patients were treated with mt.Forty-six (41.8%) patients were male.These patients had a median age of 68 (56-74) years.All procedures were performed on a monoplane flat detector angiography machine under conscious sedation.A 6 french (f) long sheath (destination, terumo) was placed on cervical segment of the ica or the common carotid artery.A distal access catheter (sofia 6f microvention; navien 5f-6f, medtronic), 0.027-inch microcatheter (headway, microvention; rebar, medtronic), and 0.014-inch microwire were advanced to the cavernous segment of ica.A microwire and microcatheter passed the occluded segment.Then, stent retriever thrombectomy (isolated stent retriever, save, arts) or direct aspiration (adapt) was performed on all patients.In the stent retriever thrombectomy, a stent retriever (eric, microvention; trevo, stryker; ape rio hybrid, acandis; thrombite, zyloxtonbridge) was placed on the occluded segment, and it was withdrawn with manual aspiration by a 50 ml syringe.A distal access catheter (sofia 6f, microvention) was advanced to the occlusion site in the direct aspiration technique.Then, manual aspiration was performed with a 50 ml syringe.The thrombectomy technique was changed after two unsuccessful attempts.The treatment was considered a failure if the vessel was not successfully recanalized after five passes.Balloon angioplasty was applied in tandem occlusions.Carotid artery stenting (cas) was performed in persistent cervical carotid occlusion despite angioplasty.The article does not state any technical issues during use of the navien or rebar the following intra- or post-procedural outcomes were noted: -eighty-three (75.5%) patients achieved successful recanalization (mtici 2b-3); 27 patients had unsuccessful recanalization -thrombectomy technique was changed in 30% (33) of patients due to failed attempts.- a total of 56 (50.9%) patients had good clinical outcome ( mrs score of =2).54 patient's had poor clinical outcome.- seventeen (15.5%) patients had ich - 4 (3.6%) patients suffered from symptomatic intracerebral hemorrhage (sich).- twenty-six (23.6%) patients died within three months of follow-up.

• 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: 19120884
• MDR Text Key: 340336813
• Report Number: 2029214-2024-00670
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• 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: 04/09/2024
• 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: 68 YR
• Patient Sex: Female