MAUDE Adverse Event Report: AV-TEMECULA-CT ACCULINK CAROTID STENT SYSTEM

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 06/01/2008

Event Type  Injury  

Event Description

This event was captured based on literature review.This retrospective study aimed to investigate the feasibility and efficacy of using self-expanding stents to treat symptomatic vertebral artery ostium (vao) stenosis in selected patients.In total, 32 patients (28 men, four women; mean age 65.6 +/- 8.6 years; range 53-84 years) were included in the investigation.Clinical and angiographic results were retrospectively reviewed in patients with symptomatic vao stenosis who underwent stenting with self-expanding stents between (b)(6) 2008 and (b)(6) 2011.In total, 32 patients were included.Self-expanding stents (25 tapered and seven non-tapered, acculink) were deployed with a modified technique of deploying the stents from the v1 segment to the proximal subclavian artery.The mean degree of stenosis before and after stenting declined from 76.4% to 11.4%.No peri-procedural complications occurred.During the mean clinical follow-up of 18.3 months, no vertebrobasilar stroke, transient ischemic attack or death occurred.During the mean angiographic follow-up of 12.5 months, asymptomatic restenosis occurred in one (3.1%) patient 6 months after the procedure.No stent fracture occurred.The involved subclavian artery was patent and no clinically apparent events occurred in the dependent upper extremity.No additional information was provided.

Manufacturer Narrative

(b)(4).Patient information, estimated: thirty-two patients (28 men, four women; mean age 65.6 +/- 8.6 years; range 53-84 years) reported.Dates; estimated based on date of publication.Incorrect anatomy; carotid device used in subclavian, vertebral.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The acculink was reportedly used in the subclavian or vertebral artery ostium and not the carotid artery as stated in the acculink instructions for use (ifu).The lot history record for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.This incident was reported with the absence of any device malfunction.As a result, a similar incident query is not required as the complaint details and the lot history record review did not reveal a potential device issue related to the reported incident.Additionally, the reported patient effect(s) of stenosis is generally a known effect associated with the use of the device and the procedures in which it is utilized.In the absence of any reported device malfunction, a potential relationship between the reported patient effect and a device issue is unlikely.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3710815
• MDR Text Key: 19920654
• Report Number: 2024168-2014-01927
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/06/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 03/31/2014
• 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
• Patient Age: 65 YR