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 Thrombosis/Thrombus (4440)

Event Date 08/23/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: ogilvy cs, natarajan sk, jahshan s, karmon y, yang x, snyder kv, hopkins ln, siddiqui ah, levy ei.Stent-assisted coiling of paraclinoid aneurysms: risks and effectiveness.J neurointerv surg.2011 mar;3(1):14-20.Doi: 10.1136/jnis.2010.002303.Epub 2010 aug 23.Pmid: 21990780.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 is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.The in-stent thrombosis was treated with intraarterial administration of medication, which resulted in the procedure being completed successfully and the patient suffered no neurological deficits.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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: ogilvy cs, natarajan sk, jahshan s, karmon y, yang x, snyder kv, hopkins ln, siddiqui ah, levy ei.Stent-assisted coiling of paraclinoid aneurysms: risks and effectiveness.J neurointerv surg.2011 mar;3(1):14-20.Doi: 10.1136/jnis.2010.002303.Epub 2010 aug 23.Pmid: 21990780.Objective and methods: the purpose of the current study was to retrospectively review our data to evaluate potential risks and overall effectiveness of self-expanding intracranial stent placement as an adjunct in the treatment of intracranial aneurysms in the paraclinoid location.In this article, paraclinoid aneurysms are defined as those that arise from the carotid artery at or distal to the dural ring and proximal to the posterior communicating artery.94 intracranial arteries aneurysms were treated between september 2001 and september 2008.Treatments were as follows: 24 patient received coiling alone, 38 stent-assisted coiling, 31 staged treatments (coiling then stenting), 1 patient treated with stand alone stenting with a competitor product.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: stent: neuroform or wingspan stent, (boston scientific) unk coils.Adverse events suspected on unknown enterprise stent: in-stent thrombus formation during coiling.Treated with medication administration and no neurological sequalae.Adverse events not associated with specific device manufacturer due to insufficient information: i symptomatic arterial spasm- no treatment specified.1 arterial spasm with edema- no treatment specified.2 arterial spasm with no neurological symptoms.2 tia- no treatment specified.There is insufficient information within the text of this article to identify which devices (s) (cerenovus or non-cerenovus) are associated with these reported complications.The complications associated with the competitor products are excluded from this complaint.

• 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: 17004947
• MDR Text Key: 316000582
• Report Number: 3008114965-2023-00339
• 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: 05/05/2023
• 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: NEUROFORM OR WINGSPAN STENT, (BOSTON SCIENTIFIC).; UNK COILS.
• Patient Outcome(s): Required Intervention