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

Model Number	82091-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paresis (1998)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat an internal carotid artery that is 99% stenosed.A 4.0x20mm viatrac balloon was used to pre-dilated the lesion successfully.An emboshield nav6 and a 8-6x30mm xact stent, were also used successfully, however, the patient was noted to experience left arm weakness post procedure.The symptom spontaneously resolved after cat scan was performed with great results.There was no clinically significant delay in 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 incidents from this lot.A conclusive cause for the reported paresis, and the relationship to the product, if any, cannot be determined.The reported patient effect of paresis is not listed in the xact carotid stent system information for prescribers as an adverse event potentially associated with carotid stents and embolic protection systems; however paresis is listed in the no-fault errors for coronary and endovascular products risk assessment as a foreseeable event.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: 21462861
• Report Number: 2024168-2025-02073
• Device Sequence Number: 18352975
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: (01)08717648010279(17)270228(10)4032861
• 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): 02/25/2025

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: 82091-01
• Device Catalogue Number: 82091-01
• Device Lot Number: 4032861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: Other
• Patient Sex: Unknown