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 Thromboembolism (2654)

Event Date 12/01/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: kanaan h, jankowitz b, aleu a, kostov d, lin r, lee k, panipitiya n, gologorsky y, sandhu e, rissman l, crago e, chang yf, kim sr, jovin t, horowitz m.In-stent thrombosis and stenosis after neck-remodeling device-assisted coil embolization of intracranial aneurysms.Neurosurgery.2010 dec;67(6):1523-32; discussion 1532-3.Doi: 10.1227/neu.0b013e3181f8d194.Pmid: 21107183.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 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, it is clinically reasonable to assume an intervention would be provided in the case of an occlusion at/near the stent site.The type of occlusion is not specified and being coded as a cerebral thrombosis.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 and the following citation was reviewed: kanaan h, jankowitz b, aleu a, kostov d, lin r, lee k, panipitiya n, gologorsky y, sandhu e, rissman l, crago e, chang yf, kim sr, jovin t, horowitz m.In-stent thrombosis and stenosis after neck-remodeling device-assisted coil embolization of intracranial aneurysms.Neurosurgery.2010 dec;67(6):1523-32; discussion 1532-3.Doi: 10.1227/neu.0b013e3181f8d194.Pmid: 21107183.Background and purpose: to examine the technical and anatomic factors that predict short- and longterm stent patency.We undertook a retrospective review of 161 patients who underwent coil embolization of 168 ruptured and unruptured aneurysms assisted by the use of a neckremodeling device.One hundred twenty-seven patients had catheter-based angiographic follow-up to evaluate 133 stent-coil constructs (mean, 15.4 months; median, 12.7 months).The technique of microcatheter jailing was used in a majority of patients; nonstandard stent configurations were also used.Cerenovus devices that were used in this study: qty unk: enterprise stents.Adverse event(s) and provided interventions associated with enterprise stent: qty 3: three patients using enterprise stents experienced in-stent thrombus.Treatments not 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 ; 303552-689
• MDR Report Key: 18530825
• MDR Text Key: 333076263
• Report Number: 3008114965-2024-00085
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 01/04/2024
• 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
• Patient Outcome(s): Life Threatening