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 Problems Intracranial Hemorrhage (1891); Paralysis (1997); Transient Ischemic Attack (2109); Obstruction/Occlusion (2422); Cognitive Changes (2551); Unspecified Nervous System Problem (4426)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Date of event: the date of the event/study is not known.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.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.Since the severity of the reported events is unknown, and the relationship of the device to the reported events cannot be disassociated, the event will be conservatively reported to the fda with the classification of "serious injury".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 database related research activity (drra).On behalf of (b)(6), medtech epidemiology, please see the drra potential complaint form, aligned to a cerenovus product, and a copy of the final study report.Device name: enterprise¿ stent.Overall complications: including: overall complications (aphasia, hemiplegia, paraplegia, cerebral artery occlusion), hemorrhagic complications (sah, intracerebral hemorrhage), neurologic, other complications (other surgical complications, ventriculostomy, ventriculoperitoneal shunt surgery, tracheostomy).Count: 38.Hemorrhagic complications: sah, intracerebral hemorrhage.Count: 7.Ischemic complications: tia, ischemic stroke.Count: 20.Neurologic complications: count: 19.Other complications: surgical complications, ventriculostomy, ventriculoperitoneal shunt surgery, tracheostomy.Count: 5.90 day all-cause readmissions: any readmission post index admission within 12 months.Count: 71.90 day uia related readmissions: readmissions related to uia.Count: 43.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16438248
• MDR Text Key: 310231898
• Report Number: 3008114965-2023-00130
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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: 02/14/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention