MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number UNK-NV-SAB

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Vasoconstriction (2126); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

See attachments for literature article.Event related to regulatory report: 2029214-2023-00372 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

Bin wang, yingjia li, ruili wu; international journal of clinical and experimental medicine; 2018; 11(8):8537-8543; clinical curative effect of mechanical thrombectomy combined with catheter aspiration for treatment of senile acute middle cerebral artery occlusion; www.Ijcem.Com /issn:1940-5901/ijcem00781 medtronic received information in a literature article that patients treated with navien, rebar catheters and solitaire ab stents had complications.The objective of the article was to investigate the clinical efficacy of mechanical thrombectomy (mt) combined with catheter aspiration for the treatment of senile acute middle cerebral artery middle cerebral artery (mca) occlusion. sixty patients (41 males and 19 females) with acute mca occlusion who were being treated in a single facility from may 2016 to may 2017 the patients were divided into the study group (n=32) which underwent mt with catheter aspiration and the control group (n=28) which underwent mt.Procedure: in the study group a sfr guiding catheter was placed in the internal carotid artery proximal to the diseased artery with the help of a 5fr navien middle catheter.At the same time, a transcend microwire and a rebar is microcatheter were placed in the distal end of the occluded vessel.The position of the occlusion was determined by microcatheter angiography, and thrombectomy was performed using a solitaire ab stent.The success of thrombectomy was evaluated based on blood flow recovery and the thrombus body in the effective segment of the stent, as seen by a middle catheter angiography.After successful thrombectomy, the middle catheter was placed at the proximal end of the thrombus after standing for 3 minutes, and the stent and thrombus were put into the middle catheter. the stent system, intermediate catheter, and microcatheter were then withdrawn, and aspiration was continuously performed with the middle catheter and guiding catheter during withdrawal. after the middle catheter was completely withdrawn, another 40-50 ml was aspirated by the guiding catheter.In the control group  the guiding catheter was placed in the internal carotid artery to open the solitaire ab stent for thrombectomy.The stent was partially recovered into the microcatheter to clamp the thrombus.Then the thrombus was withdrawn and continuously aspirated through a guiding catheter with a 50 ml syringe.After the solitaire ab stent was completely withdrawn, another 40- 50 ml was aspirated by the guiding catheter.  complications: perioperative complications including distal embolization, new arterial dissection, intracranial hemorrhage, symptoma tic intracranial hemorrhage, arterial vasospasm, and secondary cerebral infarction were observed in both groups. no severe complications such as distal embolization in the lesion area, new arterial dissection, or secondary cerebral infarction occurred during the perioperative period in either group.However, the incidences of intracranial hemorrhage, symptomatic intracranial hemorrhage, and va sospasm were significantly lower in the study group than in the control group. primary observation indexes were as follows.Vascular recanalization of thrombectomy was evaluated by grading cerebral infarction.Grade 0-2a indicates vascular non-patency and grade 2b-3 indicates recanalization.The recanalization of thrombectomy, recanalization after treatment, the time from puncture to recanaliz ation, and the time from onset to recanalization were recorded. the recanalization rate of the study group was significantly higher than that of the control group.The time from onset to recana lization and from puncture to recanalization were significantly shorter in the study group compared to the control group. after treatment, the recanalization rate of the study group was slightly higher than that of the control group.

Event Description

Additional information was received that the director noted that there were no problems during the operation.

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.

• Brand Name: SOLITAIRE AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 16449031
• MDR Text Key: 310321447
• Report Number: 2029214-2023-00373
• Device Sequence Number: 1
• Product Code: NJE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SAB
• Device Catalogue Number: UNK-NV-SAB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• 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): Required Intervention; Hospitalization