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

Model Number	82090-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994); Paresis (1998); Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed on (b)(6) 2025, to treat a moderately calcified right common carotid artery and right internal carotid artery.The 8x40mm xact carotid stent was successfully deployed in the common carotid artery.After deployment, thrombus was noted inside the stent.Thrombectomy was performed and imaging showed "no flow" to the brain.The patient experienced a transient ischemic attack with facial drooping, left side weakness, the inability to speak, pain, and hypertension.Tissue plasminogen activator was given for treatment and thrombectomy was performed again.Blood flow was restored and 2 acute clots were captured by the filter.Computed tomography scan was performed which was negative for emboli.On (b)(6) 2025, the patient was sent to the icu for further care.There were no residual deficits and the patient was able to pass neurological exams.The hypertension was not treated, nor did it resolve during the procedure.No additional information was provided.
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 similar incidents from this lot.A conclusive cause for the reported thrombosis/ thrombus, transient ischemic attack, paresis, high blood pressure/ hypertension and pain and the relationship to the product, if any, cannot be determined.The reported patient effects of vessel thrombosis, hypertension, pain and transient ischemic attack are listed in the xact carotid stent system information for prescribers as adverse events potentially associated with carotid stents and embolic protection systems.The treatment appears to be related to the operational context of the procedure.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.

• 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: 23633866
• Report Number: 2024168-2025-11728
• Device Sequence Number: 9316979
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: (01)08717648010262(17)260630(10)3072661
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/24/2025

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 Expiration Date: 06/30/2026
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 3072661
• 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: 11/12/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White