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 Stroke/CVA (1770)

Event Date 09/21/2011

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed:dorn f, prothmann s, wunderlich s, liebig t.Stent angioplasty of intracranial stenosis: single center experience of 54 cases.Clin neuroradiol.2012 jun;22(2):149-56.Doi: 10.1007/s00062-011-0106-1.Epub 2011 sep 21.Pmid: 21935719.Objective/methods/study data: purpose the aim of the study was to retrospectively evaluate the safety and efficacy of stent angioplasty of symptomatic intracranial stenosis in a single center experience.Materials and methods between november 2006 and september 2009 a total of 54 stent angioplasties were performed in 49 patients and of these 46 were done for symptomatic intracranial high-grade (>70%) stenosis and 8 for complete vessel occlusions in acute stroke.All elective treatments were carried out with patients under antithrombotic/anticoagulant medication.Self-expandable stents were used in 42 cases and balloon-expandable stents in 12 cases.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent adverse event(s) and provided interventions possibly associated with unidentified enterprise stent (table 1): patient #32 received enterprise stent experienced major stroke on day 1 after procedure (recognized procedural complication, cerebrovascular accident).Patient #34 received enterprise stent experienced minor stroke day 26 after procedure (recognized procedural complication, cerebrovascular accident).Patient #36 received enterprise stent experienced stenosis greater than 90% and stent migration 1 month after the procedure treated with a second intervention of additional stent (surgical intervention, restenosis).Patient #39 received enterprise stent experienced a thromboembolic event with transient aphasia directly after stent implantation and mri revealed a new diffusion-weighted imaging lesion day 1 after procedure (recognized procedural complication, transient ischemic attack).No interventions required.Patient #49 received enterprise stent experienced a major stroke day 1 after procedure (recognized procedural complication, cerebrovascular accident).

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed:dorn f, prothmann s, wunderlich s, liebig t.Stent angioplasty of intracranial stenosis: single center experience of 54 cases.Clin neuroradiol.2012 jun;22(2):149-56.Doi: 10.1007/s00062-011-0106-1.Epub 2011 sep 21.Pmid: 21935719.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: initial reporter address line 2: department of radiology and neuroradiology.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Patient #34 received enterprise stent experienced minor stroke day 26 after procedure (recognized procedural complication, cerebrovascular accident).Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.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.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: 18560297
• MDR Text Key: 333444805
• Report Number: 3008114965-2024-00108
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 01/12/2024
• 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): Other