MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

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

Patient Problem Hemorrhagic Stroke (4417)

Event Date 09/17/2022

Event Type  Injury  

Manufacturer Narrative

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.See attached literature article.No specific device information provided.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

(b)(6) recanalization rate and clinical outcomes of intravenous tissue plasminogen activator a dministration for large vessel occlusion stroke patients.(b)(6) neurosurg.2023.Soc 66 (2) : 144-154.Doi: 10.3340/jkns.2022.0120 summary: stroke caused from large vessel occlusion (lvo) has emerged as the most common stroke subtype worldwide.Intravenous tissue plasminogen activator administration (iv-tpa) and additional intraarterial thrombectomy (ia-tx) is regarded as standard treatment.In this study, the authors try to find the early recanalization rate of iv-tpa in lvo stroke patients.Total 300 patients undertook ia-tx with confirmed anterior circulation lvo, were analyzed retrospectively.Brain computed tomography angiography (cta) was the initial imaging study and acute stroke magnetic resonance angiography (mra) followed after finished iv-tpa.Early recanalization rate was evaluated by acute stroke mra within 2 hours after the iv-tpa.In 167 patients undertook iv-tpa only and 133 non-recanalized patients by iv-tpa, additional ia-tx tried (iv-tpa + ia-tx group).And 131 patients, non-recanalized by iv-tpa (iv-tpa group) additional ia-tx recommend and tried according to the patient condition and compliance.Early recanalization rate of lvo after iv-tpa was 12.0% (36/300).In recanalized patients, favorable outcome (modified rankin scale, 0¿2) was 69.4% (25/36) while it was 32.1% (42/131, p<(><<)>0.001).In non-recanalized patients.Among 133 patients, nonrecanalized after intravenous recombinant tissue plasminogen activator and undertook additional ia-tx, the clinical outcome was better than not undertaken additional ia-tx (favorable outcome was 42.9% vs.32.1%, p=0.046).Analysis according to the perfusion/diffusion (p/d)-mismatching or not, in patient with iv-tpa with ia-tx (133 patients), favorable outcome was higher in p/ d-mismatching patient (52/104; 50.0%) than p/d-matching patients (5/29; 17.2%; p=0.001).Which treatment tired, p/d-mismatching was favored in clinical outcome (iv-tpa only, p=0.008 and iv-tpa with ia-tx, p=0.001).The p/d-mismatching influences on the recanalization and clinical outcomes of iv-tpa and ia-tx.The authors would like to propose that we had better prepare ia-tx when lvo is diagnosed on initial diagnostic imaging.Furthermore, if the patient shows p/d-mismatching on mra after iv-tpa, additional ia-tx improves treatment results and lessen the futile recanalization.Reported events: reperfusion injury in recanalized patients (43/104 [41.3%] vs.20/29 [69.0%], p=0.007) was less in p/d-mismatching patients.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 17996139
• MDR Text Key: 326387621
• Report Number: 2029214-2023-02068
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• 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