MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

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

Patient Problems Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440)

Event Date 11/05/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Literature citation: suh sh, kim bm, roh hg, lee ky, park si, kim di, kim dj, nam hs, choi hs.Self-expanding stent for recanalization of acute embolic or dissecting intracranial artery occlusion.Ajnr am j neuroradiol.2010 mar;31(3):459-63.Doi: 10.3174/ajnr.A1865.Epub 2009 nov 5.Pmid: 19892814; pmcid: pmc7963979.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: event description literature citation: suh sh, kim bm, roh hg, lee ky, park si, kim di, kim dj, nam hs, choi hs.Self-expanding stent for recanalization of acute embolic or dissecting intracranial artery occlusion.Ajnr am j neuroradiol.2010 mar;31(3):459-63.Doi: 10.3174/ajnr.A1865.Epub 2009 nov 5.Pmid: 19892814; pmcid: pmc7963979."objective and methods: stent placement may be an effective and last resort method for recanalization of recalcitrant intracranial artery occlusion.The purpose of this study was to evaluate the safety and efficacy of a self-expanding stent for the recanalization of acute embolic or dissecting intracranial artery occlusion.Nine patients (mean age, 66 years; nihss score, 10-23) with acute embolic (n = 8) or dissecting occlusion (n = 1) of the intracranial arteries (ica terminus in 5, mca in 3, and ba in 1) were treated with a recapturable self-expanding stent.The safety and efficacy of the stent for recanalization were evaluated retrospectively.The emboli were entrapped against the vessel wall by the stent, resulting in immediate recanalization (timi 2) in all embolic occlusions.Acute in-stent thrombosis occurred in 2 patients, who received only urokinase without gp iib/iiia antagonist.Both of the reoccluded arteries were reopened, by stent recapture in 1 and by intra-arterial administration of gp iib/iiia antagonist in the other.Recapture was attempted in 7 cases, of which there were 3 successful outcomes.There was 1 asymptomatic hemorrhagic conversion at the infarction site.The authors concluded that a self-expanding stent may be safe and efficient for recanalization of acute embolic or dissecting intracranial artery occlusion.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise recapturable, self-expanding stent prowler select plus microcatheter envoy guide catheter other cerenovus devices that were also used in this study: non-cerenovus devices that were also used in this study: shuttle guide catheter (cook) adverse event(s) and provided interventions associated with cerenovus devices: 1 patient being treated for traumatic ica dissection experienced a small, asymptomatic hemorrhagic conversion of the preexisting basal ganglia infarction site during stent deployment.This required no treatment and, the authors note, resolved without sequalae.2 patients experienced acute in-stent thrombosis.One was treated with stent recapture and intraarterial administration of urokinase.The second was treated with intraarterial administration of gp iib/iii agonist.Postoperative ct imaging revealed patent arteries and full expansion of the stent.".

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH240 0; SZ CH2400
• MDR Report Key: 12566221
• MDR Text Key: 281094589
• Report Number: 1226348-2021-00072
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 09/07/2021

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 Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHUTTLE GUIDE CATHETER (COOK)
• Patient Outcome(s): Required Intervention