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

Model Number 82090-01

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

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 07/30/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment(s) appears to be related to the operational context of the procedure.The reported patient effects of vessel thrombosis and cerebral hemorrhage (cerebrovascular accident) are listed in the xact carotid stent system information for prescribers as adverse events potentially associated with carotid stents and embolic protection systems.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient had 8x40x136 xact stent implanted on (b)(6) 2022.The following morning the patient suffered right side drift and slurred speech.A computerized tomography (ct) head/neck was performed and confirmed the patient suffered a stroke.The ct did reveal the stent was occluded with thrombus.The stroke was treated with heparin and thrombosis was treated with tissue plasminogen activator (tpa).There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15267796
• MDR Text Key: 298334712
• Report Number: 2024168-2022-08986
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• 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: Physician
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 1012861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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; Hospitalization; Disability
• Patient Age: 71 YR
• Patient Sex: Male