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

Model Number UNK-NV-FG

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

Patient Problems Hematoma (1884); Pain (1994); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

Event related to regulatory report: 2029214-2024-00178.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

Julien allard, eimad shotar, kevin premat, stephanie lenck, anne-laure boch, mehdi drir, nader-antoine sourour, frederic clarencon; journal of neuroradiology; 2023; 23:46; radial artery occlusion after aneurysm treatment using the rist guide catheter: single center cohort study; doi.Org/10.1016/j.Neurad.2023.11.004 medtronic received information in a literature article of patients treated with rist guide catheters (gc) and phemon catheters having complications.The purpose of the article was to assess the rate of delayed radial artery occlusion (drao) after intracranial aneurysm (ia) treatment using the rist gc. all patients treated for an unruptured intracranial aneurysm using transradial access (tra) with the rist gc from (b)(6) 2021 to (b)(6) 2022 in a single center were screened.Systematic us-doppler assessment of the radial artery with the attending neuroradiologist at 3-months after treatment. during the study period, 298 endovascular procedure for ia treatment were performed at our institution.Among the 168 patients treated for unruptured ia, 27 patients were treated using tra and the rist gc.22 patients attended the follow-up consultation with us-doppler assessment of radial artery patency and were included in the analysis. main outcome was the presence of a drao which was defined as the absence of detectable blood flow in us-doppler.Radial artery spasm, iatrogenic arterial dissection or perforation and any per-procedural neurological complications were also part of the safety outcomes.Procedure: tra was considered in patients with a radial artery diameter >1.5 mm. the procedures were performed under general anesthesia and oral intubation by senior neuroradiologists experienced in tra.Tra was obtained initially using a 4f, 5f or 6f radial sheath depending on operator¿s preference and radial artery size. the 4f, 5f or 6f sheath were then replaced for a 7f sheath using a wire exchange maneuver.Navigation was performed using the rist system (rist 079 guide catheter and 5.5-french simmons 2 catheter) over a 0.03500 guidewire.After an antebrachial roadmap, the rist system was introduced into the 7f sheath and navigated over the guidewire in the subclavian artery.Target vessel was catheterized using a 5.5f simmons 2 cathe ter and the rist gc was advanced in the cervical internal carotid artery (ica). when a triaxial system was needed, a phenom plus over a delivery microcatheter and a 0.01400 micro guidewire was positioned distally in the parent artery. after aneurysm treatment, we used a tr-band radial compression device to remove the 7f sheath.Results: navigation of target vessel with the rist gc was successful in all cases.Tra using the rist gc allowed for complete intended procedure in 20/22 (90.9 %) patients.Tfa conversion was needed in 2 cases, both due to insufficient stability with the rist gc in the left ica.The use of a triaxial system was required in 9/22 (40.9 %) cases without any specific challenge.Patients were treated using various techniques including coiling remodeling in 9 cases, intrasaccular flow disruption in 2 cases, flow diverter stent in 8 cases and stent assisted coiling in 3 cases.At 3-month follow up, 6/22 (27.3 %) patients presented with drao.Among them 2 patients experienced post-operative wrist pain and forearm hematoma.The other 4 patients had no symptoms related to drao.For all patients, with and without drao, the ulnar artery was patent, and there were no cases of hand ischemia.Drao were mainly located at the puncture site along the length of the radial sheath (5/6 patients) and one patient presented an extensive drao from the origin to the puncture site.There were no case of radial artery spasm.One patient presented a non-symptomatic radial artery dissection after neurointervention without drao at 3-month follow-up.There were 2 cases of iatrogenic left cervical ica dissection during the initial navigation.Both patient had tortous left common carotid artery.In one case, emergent ica stenting was required to prevent an ica occlusion.There were no ischemic events related to the iatrogenic ica dissections.

• Brand Name: PHENOM
• 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: 18593027
• MDR Text Key: 333897465
• Report Number: 2029214-2024-00179
• 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: 01/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/28/2024
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female