MAUDE Adverse Event Report: NEURAVI LTD. UNK_THROMBECTOMY NEURAVI; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_THROMBECTOMY NEURAVI

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Ischemia Stroke (4418)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: in a patient that was admitted with a right middle cerebral artery m1-occlusion, 11 attempts using various thrombectomy devices and techniques were required for removal of the thrombus.After vascular access was achieved, a 95 cm 8f balloon guide catheter (bgc; flowgate, stryker neurovascular) was inserted through the sheath and positioned with the tip in the distal cervical segment of the internal carotid artery.A 0.021-in.Microcatheter (prowler select plus, codman) was advanced over a 0.014 microwire (transend-ex platinum, stryker) through the occluded distal m1- and inferior m2-segments of the right mca.The microwire was exchanged for a 5 × 33 mm stent retriever thrombectomy device (embotrap ii, cerenovus ) which was subsequently deployed in the occluded parts of the m1-m2 segments.Under temporary bgc-occlusion but without an intermediate aspiration catheter, the stent retriever was slowly retracted in three consecutive unsuccessful attempts to retrieve the clot.Technically identical procedures where then performed another three times but with a 4 × 30 mm trevo-xp provue stent retriever (stryker).These retrieval attempts were also unsuccessful with an unchanged complete occlusion.The initial stent retriever strategy was then changed to direct contact aspiration utilizing a 125 cm 5f sofia intermediate catheter (microvention), inserted through the bgc over the microcatheter and microwire, reaching the occluded segment of the right mca.Three attempts with manual aspiration were made with a 20 cc syringe, but the occlusion remained unchanged with no clot removal.Finally, the sofia intermediate catheter was replaced by the slightly larger catalyst-6 (stryke) aspiration catheter and another two attempts were made with a combination protectplus technique [10] in conjunction with the embotrap stent retriever.At the second of these two attempts, focusing on holding the clot by a steady negative pressure in the aspiration catheter during withdrawal of the stent retriever, microcatheter and aspiration catheter simultaneously under bgc-induced carotid flow-arrest, a successful retrieval of a complete clot was achieved in the eleventh removal attempt, resulting in a tici 2c revascularization.The day after the endovascular treatment a brain magnetic resonance imaging (mri) investigation was performed including diffusion-weighted- (dwi), fluid attenuated inversion recovery (flair) and contrast enhanced t1-weighted images.Dwi demonstrated restricted diffusion in the right basal ganglia and several small cortical and subcortical lesions, consistent with acute small embolic infarctions.Model and catalog number are not available, but the suspected device is embotrap.Other cnv devices that were also used in this study: prowler select plus.Non-cnv devices that were also used in this study: 8french (f).Sheath (arrow), 8f balloon guide.Catheter (bgc; flowgate, stryker), microwire (transend-ex platinum, stryker), trevo-xp.Provue stent retriever (stryker), sofia intermediate catheter (microvention), catalyst-6 (stryker).Publication details.Title: detailed histological analysis of a thrombectomy-resistant ischemic stroke thrombus: a case report.Objective: : mechanical removal of a thrombus by thrombectomy can be quite challenging.For reasons that are not fully understood, some thrombi require multiple passes to achieve successful recanalization, whereas other thrombi are efficiently removed in a single pass.Since first pass success is associated with better clinical outcome, it is important to better understand the nature of thrombectomy resistant thrombi.The aim of this study was therefore to characterize the cellular and molecular composition of a thrombus that was very hard to retrieve via mechanical thrombectomy.Methods: review of case.

• Brand Name: UNK_THROMBECTOMY NEURAVI
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12357136
• MDR Text Key: 267820224
• Report Number: 3011370111-2021-00079
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_THROMBECTOMY NEURAVI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: , SOFIA INTERMEDIATE CATHETER (MICROVENTION).; CATALYST-6 (STRYKER).; F BALLOON GUIDE CATHETER (BGC, FLOWGATE, STRYKER).; FRENCH (F) SHEATH (ARROW).; MICROWIRE (TRANSEND-EX PLATINUM, STRYKER).; REVO-XP PROVUE STENT RETRIEVER (STRYKER).; UNKPROWLERSELECT.
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR