MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISEENC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Code Available (3191)

Event Date 12/31/2014

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).No information available.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.This report was originally submitted on 8/5/2020 in which a data error was received for duplicate report number.Resubmission was attempted two more times on 8/5/2020, then again on 8/10/2020 and again on 8/14/2020 with a new report number each time, however the same data error for duplicate report number was received.Investigation was performed and the cause of this issue was discovered on 8/20/2020, in which another manufacturer (integra) was submitting reports under the same registration number, therefore causing the multiple duplicate errors we received.Therefore, this report is being resubmitted with a new number.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled ¿multicentric experience in distal-to-proximal revascularization of tandem occlusion stroke related to internal carotid artery dissection.¿ 1 patient with anterior circulation ischemic stroke treated with an endovascular approach who underwent the revascularization procedure and a cervical carotid stent placement experienced symptomatic intracranial hemorrhage in the basal ganglia occurred early despite a tici 3 recanalization.Nevertheless, the patient had a favorable outcome with an mrs of 2 after 3 months.1 patient with anterior circulation ischemic stroke treated with an endovascular approach who underwent the revascularization procedure and cervical carotid stent placement died for 3 months.The purpose of this study was to evaluate our endovascular ¿distal-to-proximal¿ strategy in the treatment of this stroke subtype in the first large multicentric cohort methods: prospectively managed stroke data bases from 2 separate centers were retrospectively studied between 2009 and 2014 for records of tandem occlusions related to internal carotid dissection.Atheromatous tandem occlusions were excluded.The first step in the revascularization procedure was intracranial thrombectomy.Then, cervical carotid stent placement was performed depending on the functionality of the circle of willis and the persistence of residual cervical ica occlusion, severe stenosis, or thrombus apposition.Cerenovus devices (stent enterprise) were used in this study.No devices specific information (including catalog and the lot number) were provided in the article.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10449970
• MDR Text Key: 204258155
• Report Number: 1226348-2020-00454
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/25/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 53 YR