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

Model Number	82087-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Ischemia (1942)
Date of Event	12/12/2025
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 similar incidents from this lot.A conclusive cause for the reported ischemia, stroke/cva and low blood pressure / hypotension and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.The reported patient effect(s) of ischemia, stroke and hypotension is listed in the xact carotid stent system information for prescribers as an adverse event potentially associated with carotid stents and embolic protection systems.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.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 the procedure was to treat an 80% stenosed de novo lesion in the left internal and common carotid artery with moderate calcification and mild tortuosity.A large emboshield nav 6 embolic protection system (eps was advance to the intended location and the filter was deployed.Pre-dilation was performed with a 4x20mm viatrac balloon, followed by implantation of the 9-7x30mm xact stent.However, post stent implantation the patient became symptomatic with aphasia, right sided hemiparesis, and difficulty following commands.Angiography revealed slow but complete flow in the internal/external carotid arteries and cerebrovascular vessels.The stent was confirmed to be patent.The patient systolic blood pressure was noted to be in the 90s.Therefore, the patient was treated with iv push phenylephrine twice.The patient's blood pressure return to baseline of in the 160s and the neurological symptoms returned to baseline.The patient was transferred to the critical care in stable condition.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: 23980183
• Report Number: 2024168-2026-00114
• Device Sequence Number: 4553769
• Product Code: NIM
• UDI-Device Identifier: 08717648010231
• UDI-Public: (01)08717648010231(17)280430(10)5051261
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/06/2026

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: 82087-01
• Device Catalogue Number: 82087-01
• Device Lot Number: 5051261
• 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: 12/12/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LARGER/7.2MM EMBOSHIELD NAV6, PART# 22438-19, LOT
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White