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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109)

Event Date 02/01/2014

Event Type  Injury  

Event Description

It was reported through a research article identifying acculink and xact stents that may be related to the following events: periprocedural transient ischemic attack, hypotony (hypotension) requiring reduction of anti-hypertensive agents, fluid infusion, and transient catecholamines infusion.

Manufacturer Narrative

(b)(4).The reported patient effects of hypotension and transient ischemic attack (tia) are known observed and potential patient effects as listed in the xact carotid stent system instruction for use.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.The acculink referenced is being filed under a separate medwatch report.

• Brand Name: XACT 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: 4179087
• MDR Text Key: 18726975
• Report Number: 2024168-2014-06740
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040038
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• 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
• Date Manufacturer Received: 09/23/2014
• 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
• Treatment: EMBOLIC PROTECTION: EMBOSHIELD NAV6
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR