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

Catalog Number UNKENTERPRISE

Device Problem Migration (4003)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 09/07/2011

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.E.1: the initial reporter contact information is not available.H.4: the device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: spiotta am, wheeler am, smithason s, hui f, moskowitz s.Comparison of techniques for stent assisted coil embolization of aneurysms.J neurointerv surg.2012 sep;4(5):339-44.Doi: 10.1136/neurintsurg-2011-010055.Epub 2011 sep 7.Pmid: 21990514.Background and purpose:.The purpose of this investigation is to compare the various techniques of stent assisted coiling (sac) at a single institution with regards to clinical, technical and angiographic complications and success.Patients who underwent sac between 2003 and 2010 were identified.Clinical charts, procedures, angiographic and non-invasive radiological images were analyzed to determine the anatomical and procedural details and adverse events.Immediate post-procedural angiograms as well as follow-up imaging were studied to assess the degree of aneurysm occlusion.260 aneurysms were identified.Cerenovus devices that were used in this study: qty unk: enterprise stents non-cerenovus devices that were also used in this study: qty unk: neuform, neuroform2 and neuroform3 stents (boston scientific); unknown coils the article provides insufficient information to associate adverse event(s) to specific device manufacturer.Exact product quantities cannot be accurately determined as patients can experience more than one adverse event.Adverse event(s) and provided interventions not identified to be associated with specific device manufacturer's device: intraprocedural adverse events categorized by stenting technique: mechanical, stent related (stent migration, misplacement, failed deployment): qty 21 patients.Thrombolic events (overall): qty (b)(4).No treatments listed.

• 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 ; 3035526892
• MDR Report Key: 18503571
• MDR Text Key: 333322962
• Report Number: 3008114965-2024-00054
• 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: Other
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• 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: NEUROFORM ATLAS® STENT SYSTEM (STRYKER).