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); Unspecified Infection (1930); Ischemia Stroke (4418)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: settarzade e, peker a, topcuoglu ma, arsava em, demircin m, arat a.Clinical challenges associated with the endovascular treatment of acute stroke in a patient with infective endocarditis.J cerebrovasc endovasc neurosurg.2020 sep;22(3):176-181.Doi: 10.7461/jcen.2020.22.3.176.Epub 2020 sep 21.Pmid: 32971576; pmcid: pmc7522393.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter phone: (b)(6).The device manufacture date is not known as the device lot number is not available / not reported.As the clot was very hard to traverse, we opted to deploy a closed-cell intracranial stent through a 0.021-inch microcatheter.The post-procedural nihss score was 3.However, a control brain ct without contrast obtained several hours after the procedure showed bilateral small intraparenchymal hemorrhagic lesions and a focal subarachnoid hemorrhage.Transthoracic and transesophageal echocardiogram revealed a 17×5 mm vegetation on the ventricular aspect of the mitral valve and a diagnosis of infective endocarditis was made.The patient was kept on iv tirofiban during follow-up and underwent valve replacement under tirofiban infusion on the fifth day of the endovascular procedure.Two control angiograms at 2 months and 6 months showed stent patency with persistent residual stenosis.Magnetic resonance (mr) perfusion imaging at 10 months showed a chronic infarct of the putamen and no significant perfusion asymmetry between the two hemispheres.Since this event required medical intervention or prolonged hospitalization for treatment or prevention of permanent damage to the patient, this event is mdr reportable.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

This complaint is from a literature source and the following citation was reviewed: settarzade e, peker a, topcuoglu ma, arsava em, demircin m, arat a.Clinical challenges associated with the endovascular treatment of acute stroke in a patient with infective endocarditis.J cerebrovasc endovasc neurosurg.2020 sep;22(3):176-181.Doi: 10.7461/jcen.2020.22.3.176.Epub 2020 sep 21.Pmid: 32971576; pmcid: pmc7522393.Objective and methods: this case report is of a 40-year-old man who presented with left middle cerebral artery occlusion of unknown cause.This article discusses the consequences of the fibrotic and inflammatory content of the embolus and the associated high risk of intracranial hemorrhage which complicates clinical decision-making.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: enterprise.Other concomitant cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions: a 40-year-old male presented to the emergency department with an acute onset of dysarthria and facial paralysis.Initial imaging work-up revealed no signs of ischemia on a non-contrast head computed tomography (ct) and occlusion of the superior trunk of the left middle cerebral artery on ct-angiography.A cerebral angiogram under general endotracheal anesthesia confirmed total occlusion of the superior trunk of the left middle cerebral artery (mca).As the clot was very hard to traverse, we opted to deploy a closed-cell intracranial stent through a 0.021-inch microcatheter.The post-procedural nihss score was 3.However, a control brain ct without contrast obtained several hours after the procedure showed bilateral small intraparenchymal hemorrhagic lesions and a focal subarachnoid hemorrhage.Transthoracic and transesophageal echocardiogram revealed a 17×5 mm vegetation on the ventricular aspect of the mitral valve and a diagnosis of infective endocarditis was made.The patient was kept on iv tirofiban during follow-up and underwent valve replacement under tirofiban infusion on the fifth day of the endovascular procedure.Two control angiograms at 2 months and 6 months showed stent patency with persistent residual stenosis.Magnetic resonance (mr) perfusion imaging at 10 months showed a chronic infarct of the putamen and no significant perfusion asymmetry between the two hemispheres.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; 325 paramount dr.; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16922277
• MDR Text Key: 315170588
• Report Number: 3008114965-2023-00290
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: H60001
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• 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
• Patient Outcome(s): Required Intervention