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

Catalog Number UNKENTERPRISE

Device Problem Migration (4003)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 02/19/2010

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: dashti sr, fiorella d, toledo mm, hu y, mcdougall cg, albuquerque fc.Proximal migration and compaction of an enterprise stent into a coiled basilar apex aneurysm: a posterior circulation phenomenon? j neurointerv surg.2010 dec;2(4):356-8.Doi: 10.1136/jnis.2010.002444.Epub 2010 aug 23.Pmid: 21990647.Background and purpose: a patient with a giant partially thrombosed basilar apex aneurysm was treated with balloon-assisted coil embolization.At the conclusion of the embolization, an enterprise stent was placed from the upper basilar artery to the left p1 segment.Follow-up angiography 4 months later showed that the distal stent had pulled out of the posterior cerebral artery and was in the coil mass within the aneurysm.Angiography clearly showed that the stent had migrated down the basilar artery and that the artery was now kinked proximal to the stent.Nonetheless, the left posterior cerebral artery and the basilar artery were still widely patent.This is the first documented case in which a stent ¿compacted¿ into a completed coiled aneurysm in a delayed fashion cerenovus devices that were used in this study: qty 1 enterprise stent adverse event(s) and provided interventions associated with the enterprise stent: qty 1: 1 patient with stent migration to proximal basilar artery.Patient had neurological impairment and the stent migration was found on the 4-month follow-up visit.The patient was treated with an additional surgical intervention: additional coiling to the aneurysm.

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.Since the event is life threatening and it required a medical/surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The event is reportable to the us fda.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.

• 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: 18503935
• MDR Text Key: 332895473
• Report Number: 3008114965-2024-00055
• 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?: Yes
• 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
• Patient Outcome(s): Required Intervention; Life Threatening