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 Problem Embolism/Embolus (4438)

Event Date 01/15/2013

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: galal a, bahrassa f, dalfino jc, boulos as.Stent-assisted treatment of unruptured and ruptured intracranial aneurysms: clinical and angiographic outcome.Br j neurosurg.2013 oct;27(5):607-16.Doi: 10.3109/02688697.2012.757292.Epub 2013 jan 15.Pmid: 23316930.Objective and methods: this retrospective study includes 43 patients with wide-necked, fusiform or blister aneurysms treated with stent-assisted coiling or stent alone.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: enterprise stent other cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: neuron delivery catheter 6f guide catheter or a 6f guide sheath and 6f (penumbra inc), neuroform stent systems (boston scientific) this complaint will capture all adverse events potentially associated with cnv devices.Any adverse events associated with competitors or unknown products or attributed to the patient¿s preexisting conditions will be excluded.Adverse event(s) and provided interventions associated with cerenovus devices: a 61-year-old female patient presented with right middle cerebral artery (mca) embolus, recanalized with intra-arterial abciximab with good angiographic results.A 44-year-old male patient presented with right thalamic thromboembolism and infarction.A 74-year-old female patient presented with an embolic stroke during the first procedure.The event was treated with internuclear ophthalmoplegia (ino).The event was resolved completely over 6 months.In addition during the procedure, the stent was displaced.A 46-year-old female patient experienced an asymptomatic right posterior cerebral artery (pca) occlusion.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: galal a, bahrassa f, dalfino jc, boulos as.Stent-assisted treatment of unruptured and ruptured intracranial aneurysms: clinical and angiographic outcome.Br j neurosurg.2013 oct;27(5):607-16.Doi: 10.3109/02688697.2012.757292.Epub 2013 jan 15.Pmid: 23316930.Since this event required medical intervention or prolonged hospitalization for treatment or prevention of permanent damage to the patient, the event is being reported to the us fda as a conservative measure.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.

• 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: 16967487
• MDR Text Key: 315660408
• Report Number: 3008114965-2023-00314
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 05/04/2023
• 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
• Treatment: 6F GUIDE SHEATH AND 6F (PENUMBRA INC).; NEUROFORM STENT SYSTEMS (BOSTON SCIENTIFIC).; NEURON DELIV CATH 6F GIDE CATH (PENUMBRA INC).
• Patient Outcome(s): Required Intervention; Life Threatening