MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	82096-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported this was a procedure to treat a right internal carotid artery.It was noted the artery had very soft plaque.An xact carotid stent system was inserted and deployed without issues.However, after all devices were removed, the left side of the patient was slow to respond.Medications were administered and the patient was able to recover.The physician stated there were no issues with the devices and the stroke-like symptoms were more than likely caused by a piece of soft plaque that dislodged.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information, a conclusive cause for the reported patient effect of transient ischemic attack (tia), and the relationship to the product, if any, cannot be determined.Tia is listed in the xact instructions for use as a known potential adverse effect associated with carotid stents and embolic protection systems.The additional treatment with medication was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XACT CAROTID STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 13152639
• Report Number: 2024168-2022-00015
• Device Sequence Number: 12099414
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: 08717648010323
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 11/30/2023
• Device Model Number: 82096-01
• Device Catalogue Number: 82096-01
• Device Lot Number: 0120361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 80 KG