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

Catalog Number UNKENTERPRISE

Device Problems Break (1069); Premature Activation (1484)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2010

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: chen m, goldstein-smith l.Endovascular rescue of a misshapen intracranial stent: report of two cases.J neurointerv surg.2011 mar;3(1):25-6.Doi: 10.1136/jnis.2010.002584.Epub 2010 aug 25.Pmid: 21990782.Objective and methods: inadvertent deformation and displacement of a fully deployed closed-cell intracranial nitinol stent may occur with the manipulation of other devices through or beyond them.Such displaced and deformed stents may obstruct the lumen, risking the formation of thromboembolic, and/or fail to no function as a scaffold to assist with coil embolization.This article presents two cases where the deployed intracranial stent was misshapen.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: 4.5 mm x 22 mm enterprise stent.Other concomitant cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: alligator retrieval device (ard) (ev3) adverse event(s) and provided interventions: a 62-year-old woman underwent preventative aneurysm coil embolization.The stent was inadvertently deployed proximal to the target lesion.Attempts to gain access to the aneurysm through this stent resulted in stent deformation, obstructing the vessel lumen.The proximal radio-opaque markers were splayed, suggesting a constricted, buckled stent.A microcatheter could not be advanced past the deformed stent.A 61-year-old woman underwent coil embolization for a fusiform aneurysm dome remnant.Subsequent microcatheter selection of the aneurysm across the stent interstices led to stent deformation.The proximal radio-opaque markers were seen to constrict and migrate distally.The stent no longer functioned as an effective scaffold with attempts at coil embolization.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: chen m, goldstein-smith l.Endovascular rescue of a misshapen intracranial stent: report of two cases.J neurointerv surg.2011 mar;3(1):25-6.Doi: 10.1136/jnis.2010.002584.Epub 2010 aug 25.Pmid: 21990782.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.Since these events required medical intervention or prolonged hospitalization for treatment or prevention of permanent damage to the patient, the events are 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: 16998484
• MDR Text Key: 315911512
• Report Number: 3008114965-2023-00336
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: ALLIGATOR RETRIEVAL DEVICE (ARD) (EV3).
• Patient Outcome(s): Required Intervention