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

Catalog Number 1011343-40

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

Patient Problems Death (1802); Stenosis (2263)

Event Date 11/18/2013

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012 a 6-8x40mm rx acculink stent and a 4.0x23mm xience drug eluting stent were implanted in the 80% stenosed left internal carotid artery without issue.On (b)(6) 2013, approximately 1.5 years post stent implantation, the patient was found to have a 90% focal, short stenosis in the distal stents and carotid endarterectomy was recommended.On (b)(6) 2014, the patient was hospitalized and left carotid endartectomy was performed with removal of both stents, resolving the event.On (b)(6) 2014, the patient was discharged home.On (b)(6) 2014, the patient died from a myocardial infarction.Per the physician, the death was not related to the device or procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).The xience otw stent mentioned is being filed under a separate medwatch report.There was no reported device malfunction and the product was not returned.The reported patient effect of stenosis is a known observed and potential patient effect as listed in the instructions for use (ifu).Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.

• Brand Name: RX 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: 3867336
• MDR Text Key: 17391446
• Report Number: 2024168-2014-03742
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/22/2014

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
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 1011343-40
• Device Lot Number: 2032061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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
• Treatment: STENT: 4.0X23MM XIENCE OTW
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 88