MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK XACT

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

Patient Problems Stroke/CVA (1770); Occlusion (1984); Stenosis (2263)

Event Date 12/08/2019

Event Type  Injury  

Manufacturer Narrative

Date of event estimated as (b)(6) 2019.Date of implant estimated as (b)(6) 2001.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of stroke, restenosis and occlusion are listed in the xact instructions for use as known potential patients effects associated with the use of the device.A conclusive cause for the reported occlusion, stenosis and stroke, and the relationship to the product, if any, cannot be determined.Based on the case information, 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 issue with respect to manufacture, design or labeling.The udi is unknown because the part and lot #s were not provided.Article title: severe, recurrent in-stent carotid restenosis: endovascular approach, risk factors.Results from a prospective academic registry of 2637 consecutive carotid artery stenting procedures (target-cas).The additional devices referenced are being filed under separate medwatch report#s.

Event Description

It was reported through a research article identifying xact, acculink, omnilink, and herculink devices which may be related to stroke, occlusion and stenosis.Specific patient information is documented as unknown.Details are listed in the attached article, titled: severe, recurrent in-stent carotid restenosis: endovascular approach, risk factors.Results from a prospective academic registry of 2637 consecutive carotid artery stenting procedures (target-cas).

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10258304
• MDR Text Key: 198530064
• Report Number: 2024168-2020-05664
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XACT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability