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

Catalog Number 82098-01

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).There was no reported device malfunction, and the product was not returned.The reported patient effects of transient ischemic attack 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 issue with respect to manufacture, design, or labeling.A review of the lot history record revealed no non-conformances.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a 10x30mm xact stent was implanted without issue in the right common carotid artery (cca) with moderate calcification and scar tissue due to a previous enderectomy; however, less than 24 hours later the patient had a transient ischemic attack (tia).Reportedly the cause of the tia is unknown.No thrombosis was noted and the stent was fully patent.The patient was treated medically and the symptoms were resolved.There was no clinically significant delay in the procedure.No additional information was provided.

• 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 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5502611
• MDR Text Key: 40394656
• Report Number: 2024168-2016-01627
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 82098-01
• Device Lot Number: 4120461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 90