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

Model Number	82091-01
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified, mildly tortuous right internal carotid artery.The 8x30x136 xact stent was implanted without issue.However, post-procedure the same day, the stent collapsed causing an occlusion.The patient was given blood pressure medication to increase blood pressure and contralateral flow.No further treatment was provided.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.It is possible that interaction with the heavily calcified and mildly tortuous anatomy and/or other devices resulted in the reported stent material deformation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported material deformation cannot be determined.Additionally, the reported difficulties possibly caused/contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.The reported patient effect of occlusion is listed in the xact carotid stent system information for prescribers as an adverse event potentially associated with carotid stents and embolic protection systems.Additionally, stent deformation, collapse, fracture, and movement of stent 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.

• 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: 21766999
• Report Number: 2024168-2025-03468
• Device Sequence Number: 18258644
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: (01)08717648010279(17)270131(10)4021361
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 4021361
• 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: 03/12/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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
• Patient Sex: Female