MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XACT¿; STENT, CAROTID

Model Number	83031-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.A conclusive cause for the reported thrombosis/ thrombus and stroke/cva and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.The reported patient effects of vessel thrombosis and stroke is listed in the xact carotid stent system information for prescribers as an adverse event potentially associated with carotid stents and embolic protection systems.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 9tx40 xact stent was implanted in the left internal carotid and common carotid with great post procedure flow; however, 36 hours after the procedure, the patient suffered a stroke and confirmed via ct scan.Stent thrombosis was confirmed via angiogram.Therefore, thrombectomy was performed in the left carotid artery and flow was restored.The patient was discharged 24 hours later with anti-platelet therapy.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XACT¿
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 22580621
• Report Number: 2024168-2025-07630
• Device Sequence Number: 15224452
• Product Code: NIM
• UDI-Device Identifier: 08717648356674
• UDI-Public: (01)08717648356674(17)270731(10)408146Q
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: 83031-01
• Device Catalogue Number: 83031-01
• Device Lot Number: 408146Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Sex: Unknown