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 Problem Edema (1820)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.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.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 1226348-2020-00048.Are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled ¿use of intracranial stent as rescue therapy after mechanical thrombectomy failure¿9-year experience in a comprehensive stroke centre¿ ascular treatment for acute stroke experienced symptomatic intracranial haemorrhage.1 patient with large vessel occlusion in distal internal carotid artery or proximal middle cerebral artery who underwent endovascular treatment for acute stroke experienced cerebral oedema.Purpose there is no established rescue treatment in patients with mechanical thrombectomy (mt) failure.Our aim is to analyses whether the use of an intracranial stent improves prognosis in these patients.Methods: retrospective analysis of a prospective cohort of patients with ischemic stroke due to middle cerebral artery occlusion (mca) or distal intracranial carotid artery (ica) occlusion, from september 2009 to april 2019.Patients with mt failure were identified and dichotomized into two groups according to whether or not an intracranial stent was implanted.We analysed clinical outcomes in both groups.

• 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: 10368070
• MDR Text Key: 203893650
• Report Number: 1226348-2020-00047
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• 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

• Date FDA Received: 08/05/2020
• 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
• Date Manufacturer Received: 07/15/2020
• 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): Other
• Patient Age: 62 YR