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 Vasoconstriction (2126)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(6).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 no lot number was provided by the customer.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.This is one of four products involved with the reported complaint and the associated manufacturer report numbers are  1226348-2019-01014, 1226348-2019-01016, 1226348-2019-01017.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿application of high-resolution c-arm ct combined with streak metal artifact removal technology for the stent-assisted embolization of intracranial aneurysms.¿ 5 patients with intracranial aneurysms who underwent stent-assisted embolization experienced cerebral vasospasm.The goal of this study was to evaluate the utility of high-resolution c-arm ct combined with streak metal artifact removal technology for stent-assisted embolization of intracranial aneurysms.Materials and methods: from october 2017 to july 2018, the first affiliated hospital of zhengzhou university treated 107 patients with intracranial aneurysms (118 aneurysms in total) with stent assisted embolization.Conventional c-arm ct and high-resolution c-arm ct scanning of the stented area were performed during and after treatment.3d images were reconstructed with and without streak metal artifact removal techniques.Subsequently, the image quality was compared.The reconstructed images indicated the stent deployment degree and packing density.Follow-up assessments included clinical and angiographic outcomes and complications.

Manufacturer Narrative

This correction related to a literature source entitled, ¿application of high-resolution c-arm ct combined with streak metal artifact removal technology for the stent-assisted embolization of intracranial aneurysms¿ quantity of product involved should be updated from 5 to 1.A total of 118 intracranial stents were successfully used for the embolization of 118 aneurysms.11 of these 118 stents were enterprise, so 9.32% of patients received an enterprise stent.Therefore, it can be surmised that 9.32% (11 ÷1 18 = 0.0932) of the patients who had spasm received the enterprise stent -> 0.466 ~ 1 patient.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9286513
• MDR Text Key: 165370162
• Report Number: 1226348-2019-01015
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• 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
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR