MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARKSMAN

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

Patient Problems Ischemia (1942); Paresis (1998); Dizziness (2194); Rupture (2208); Thromboembolism (2654)

Event Date 10/01/2010

Event Type  Injury  

Event Description

The purpose of the article was to report in a multicenter series the preliminary treatment experience of mca aneurysms with flow disruption by the web.Thirty-three patients with 34 mca aneurysms were treated with the web in 5 european centers.The ability to successfully deploy the web, procedure- and device related adverse events, morbidity and mortality of the treatment, and short-term angiographic follow-up results were analyzed.From october 2010 to july 2012, 33 patients (28 women and 5 men) 35 to 77 years of age (mean 55.8) harboring 34 mca aneurysms were treated with the web device in 5 centers (14, 8, 5, 3, and 3 patients in each center).The web device was successfully deployed in 33 of the 34 aneurysms (97.1%).In 1 patient, the transverse diameter of the aneurysm was 5.5 mm, and neither the 6-mm-diameter device nor the 5-mm-diameter device was appropriate for aneurysm occlusion.The aneurysm was treated with stenting and coiling.This patient was excluded from further analyses.In 1 of 32 patients (3.1%), intraoperative rupture was observed after the web was deployed in a daughter sac.The rupture was treated rapidly with coils and glue with successful occlusion of the rupture site but with occlusion of 1 branch of the mca bifurcation.The patient developed an ischemic lesion with hemiparesis.After 3 months, the patient still has a deficit and was evaluated as having an mrs score of 3.In 5 of 32 patients (15.6%), thromboembolic events were observed.In 3 patients, events occurred under antiplatelet treatment (1 medication), whereas in 2 patients, no antiplatelet treatment was given.In 3 cases, events were noticed intraoperatively by dsa and treated with intra-arterial administration of thrombolytics, and no clinical worsening occurred (mrs score, 0 in the 3 patients).Thromboembolic events with clinical worsening were observed in 2 of 32 patients (6.3%).In 1 patient, the procedure was uneventful, but a transient hemiparesis was observed in the postoperative period.In another case, thrombus in an mca branch was observed during the procedure and treated by intra-arterial administration of thrombolytics.Postoperatively, the patient had hemiparesis and vertigo, and magnetic resonance imaging showed an ischemic lesion in the pons, probably related to the diagnostic angiography performed before the endovascular treatment.At 1 month, the patient had an mrs score of 1.Finally, these 2 patients, although initially symptomatic, had mrs scores of 0 and 1 at 1 month.No treatment-related mortality was observed (0.0%).Treatment morbidity (mrs score $ 2) was encountered in 1 of the 32 patients (3.1%).Web flow disruption seems to be a promising technique for the treatment of complex mca aneurysms, particularly those with a wide neck or unfavorable dome-to-neck ratio. adverse events included: intraoperative, rupture, ischemic lesion with hemiparesis, transient hemiparesis, thromboembolic events, transient hemiparesis, thrombus in an mca branch, vertigo.

Manufacturer Narrative

Pierot l, klisch j, cognard c, szikora i, mine b, kadziolka k, sychra v, gubucz i, januel ac, lubicz b.Endovascular web flow disruption in middle cerebral artery aneurysms: preliminary feasibility, clinical, and anatomical results in a multicenter study.Neurosurgery.2013; 73:27¿35.Www.Neurosurgery-online.Com refer to regulatory rep #: 2029214-2023-00361 for related event information.56 years is the average age of the patients who participated in the study.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: MARKSMAN
• 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: 16439887
• MDR Text Key: 310230918
• Report Number: 2029214-2023-00362
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARKSMAN
• Device Catalogue Number: UNK-NV-MARKSMAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• 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: 56 YR
• Patient Sex: Female