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

Catalog Number UNKENTERPRISE

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Dysphagia/ Odynophagia (1815); Vasoconstriction (2126); Visual Impairment (2138); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 01/01/2009

Event Type  Injury  

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed mocco j, snyder kv, albuquerque fc, bendok br, alan s b, carpenter js, fiorella dj, hoh bl, howington ju, jankowitz bt, liebman km, rai at, rodriguez-mercado r, siddiqui ah, veznedaroglu e, hopkins ln, levy ei.Treatment of intracranial aneurysms with the enterprise stent: a multicenter registry.J neurosurg.2009 jan;110(1):35-9.Doi: 10.3171/2008.7.Jns08322.Pmid: 18976057.Objective and methods: the purpose of the current study for the authors to establish a collaborative registry across multiple institutions to rapidly provide large-volume results regarding their initial experience utilizing the enterprise stent in 143 aneurysms.The manufacturer of the coils, catheters, and access devices are unknown.Results regarding initial experience in using the enterprise in real-world practice.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: n/a.Adverse events suspected on unknown enterprise stent: 1 stent-assisted coiling procedure converted to a staged coiling secondary to stent movement when withdrawing the delivery catheter (additional procedure, stent: migration).1 stent-assisted coiling procedure converted to a staged coiling secondary to stent movement (additional procedure, stent: migration).1 aborted coiling secondary to stent movement (modified surgical procedure, stent: migration).2 inaccurate stent deployments- procedures completed successfully (stent: deployment difficulty: inaccurate placement, insufficient information) 1 vasospasm after stent deployment- no treatment specified.(vasospasm, insufficient information).1 asymptomatic air embolism- no treatment specified (insufficient information, air embolism) 1 acute in-stent thrombosis treated with medication administration (thrombosis, medication required).1 intraprocedural stroke- no treatment specified (cerebrovascular accident, insufficient information).2 temporary neurological deficits noted postoperatively: right drift with dysphagia in one patient and a blind spot in another.Both resolved without sequelae or treatment.(neurological impairment, transient blindness, dysphagia, minor injury).The complications associated with the unknown products are excluded from this complaint.".

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed mocco j, snyder kv, albuquerque fc, bendok br, alan s b, carpenter js, fiorella dj, hoh bl, howington ju, jankowitz bt, liebman km, rai at, rodriguez-mercado r, siddiqui ah, veznedaroglu e, hopkins ln, levy ei.Treatment of intracranial aneurysms with the enterprise stent: a multicenter registry.J neurosurg.2009 jan;110(1):35-9.Doi: 10.3171/2008.7.Jns08322.Pmid: 18976057.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e.1: the initial reporter phone and email address are not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Although no specific intervention is stated for the neurological deficits, vasospasm, cva, air embolism, it is clinically reasonable to assume an intervention would be provided.All events are being reported to the us fda as a conservative measure as follow-up will not be conducted for articles older than 10 years.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: 17005631
• MDR Text Key: 316000502
• Report Number: 3008114965-2023-00340
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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: 05/08/2023
• 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): Life Threatening; Required Intervention