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

Catalog Number 82086-01

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 08/20/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, an xact stent was placed in a carotid artery without noted issue.Post-procedure, the patient was noted in good condition.On (b)(6) 2014, the patient showed signs of a stroke and received an magnetic resonance imaging (mri) on (b)(6) 2014.A transient ischemic attack was diagnosed and the patient experienced facial deficiencies.There was no treatment reported.There was no additional information provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning and there was no report of a device malfunction.The reported patient effect of a neurological event is a known observed and potential patient effect as listed in the xact carotid stent system instruction for use.Although a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency.

• 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: 4086435
• MDR Text Key: 4827392
• Report Number: 2024168-2014-05868
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/21/2014

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 Catalogue Number: 82086-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/12/2014
• 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