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 Problems Intracranial Hemorrhage (1891); Failure of Implant (1924); Thromboembolism (2654)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

Event related to regulatory report: 2029214-2023-01916.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

Yijie huan, xiaohuan shu, liangtong huang, wei li, zheyu jin, xueping chen, ke wang, yanli zhan, weiming lan, xueli cai; clinical neurology and neurosurgery; 2023; 230: 107793; the evaluation and treatment of acute anterior circulation occlusion stroke with high clot burden: progressive stratified aspiration thrombectomy vs.Stent retriever thrombectomy; doi.Org/10.1016/j.Clineuro.2023.107793.Medtronic received information in a literature article regarding patinets treated with solitaire devices, echelon catheters, and rebar catheters.The purpose of the article was to evaluate the safety and effectiveness of the progressive stratified aspiration thrombectomy (psat) in treatment of patients with acute ischemic stroke and large vessel occlusion (ais-lvo).Patients with ais-lvo who underwent emergency endovascular treatment from (b)(6) 2018 to (b)(6) 2021 at the study institution were retrospectively studied.117 ais-lvo patients with high clot burden who underwent emergency endovascular treatment were included.All patients choose treatment according to their own wishes and divided into two groups according to surgical technique: psat group and stent retriever thrombectomy (srt) group. a total of 156 patients with ais-lvo were enrolled, among which 39 cases were excluded due to surgical changes.Therefore, 117 cases were finally included, including 65 patients (median age, 70 years; 44 males [67.7 %]) treated with psat and 52 patients (median age, 72.5 years; 38 males [73.1 %]) treated with srt.Procedure: endovascular treatment was performed with the support of neuro angiography equipment by 2 doctors with more than 10 years of neuro-intervention experience.The method of anesthesia was selected according to the individual conditions of the patients; local infiltration anesthesia was the first choice.The shape of the blood vessel, the position of the thrombus, the collateral circulation, and the length of the thrombus, were all checked sequentially.Finally, the patients underwent the interventional treatment method, srt or psat.Srt technique: srt was performed with the stent (solitaire sfr 5-30 and 6-30, solitaire ab neurovascular remodeling device).When the operator fails to restore effective blood flow after at least 3 revascularization attempts at the same occlusion segment, the surgical changes was considered.The methods include the interchange of aspiration thrombectomy and srt, balloon-assisted angioplasty and emergency stent implantation.In the case of severe vascular stenosis during the operation, remedial treatment was carried out by balloon dilatation and emergency stent implantation.Psat technique: step 1, score and evaluate: the microcatheter (echelon-10 micro cather, 105-5091-150, rebar-18 micro cather, 105-508 1-153) and microwire (synchro 2641) were used to explore the occlusion.Simultaneously, angiography was used to score clot burden and evaluate the distal compensation.Multi-angle angiography to make sure the thrombus was fully present.A microcatheter were used for local angiography and measure thrombus length.Step 2, stratified aspiration: for multisegmental occlusion, suction was successively performed from the common carotid artery, the initial segment of the internal carotid artery, the end of the internal carotid artery, and the middle cerebral artery.If the common carotid artery or internal carotid artery was occluded, an 8 f guiding catheter should be used to draw from the initial segment of the common carotid artery or internal carotid artery to the responsible vessel occlusion site in order to gradually reduce the thrombus burden.Meanwhile, the 8 f catheter was placed into the distal segment of the internal carotid artery as far as possible.If the thrombus was at the end of the internal carotid artery or m1 segments of the middle cerebral artery, a 5.4 f reperfusion catheter (penumbra system ace60) or 6 f reperfusion catheter (penumbra system ace68) was u sed for suction.If the thrombus was in the m1 and m2 segments of the middle cerebral artery, a 3.8 f reperfusion catheter (penumbra system max) or 4.3 f reperfusion catheter (penumbra system max) was use for suction. step 3, progress and repeat: continue into the next occlusion segment, subsequently the microcatheter was placed along the micro guidewire into the next responsible vessel occlusion segment and reaches the distal end of the thrombus, then slowly advanced along the micro guidewire and the microcatheter.Using coaxial technology, the suction catheter was provided with stable support through the microcatheter and the micro guidewire, so that the suction catheter advances along the micro guidewire.After the microcatheter conforms to the curvature of the blood vessel, the tip of the suction catheter was advanced as close as possible to the thrombus core.At this point, a suction pump (penumbra engine) or suction syringe was connected for negative pressure suction.Wait until the blood flow at the proximal end is restored, then gradually advance into the distal end, and maintain continuous negative pressure suction during this period.Now, the suction catheter was slowly withdrawn until the speed of the blood flow in the negative pressure pump connection tube returned to normal.Finally, the suction catheter was remove, and the thrombus was confirmed to suck out of the body or attached to the front end of the catheter.If the blood flow was not recovered, the negative pressure was maintained and the suction catheter was pulled out of the body.This method was repeated until all occluded blood vessels were re-opened.Step 4 re-evaluate and finish: when mtici grade = 2b, cerebral angiography was used to evaluate hemodynamic changes, and to ensure all the thrombus had been removed.After the operation, the rem oved thrombus should be photographed and measured.If the removed thrombus was multi-segmented, we measured the length of each formed thrombus and calculated the total length.Results: the recanalization rate of psat group was (b)(4), which was higher than that of srt group (71.2 %).There was no statistical difference between two groups in the rate ofremedial treatment (15.4 % vs.13.5 %) and thrombus migration (7.7 % vs.11.5 %). the nihss score on the 7th day of admission of psat group was statistically lower than that of srt group (12 [10¿18] vs.12 [8¿25]).There was no significant difference in terms of the 24-h nihss score after surgery (15 [10¿18] vs.15 [10¿22]),  symptomatic intracranial hemorrhage (sich) rates between the two groups (23.1 % vs.26.9 %).In psat group, 28 patients had a favorable functional outcome during the 90-day follow-up, while 15 patients in srt group.The functional outcome of the psat group was relatively better than that of the srt group (43.1 % vs.28.8 %).The mortality rate of the two groups was 13.4 % and 19.2 % during follow-up, respectively, and with no statistically significant difference.

• 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: 17854093
• MDR Text Key: 324734523
• Report Number: 2029214-2023-01917
• Device Sequence Number: 1
• Product Code: NRY
• 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
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male