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

Model Number	82090-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresis (1998); Nervous System Injury (2689); Thrombosis/Thrombus (4440)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
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.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The reported patient effects of neurological complications and thrombosis are listed in the xact instructions for use as known potential patient effects potentially associated with carotid stents and embolic protection systems.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The additional non-surgical treatment (unexpected medical intervention) and medication was related to operational context.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the common carotid artery.An 8x40mm xact self-expanding stent system (sess) was used without issue.One hour after the procedure, the patient developed hemiparesis of the right limb, slurred speech, and thrombosis.Suction, thrombectomy, and thrombolysis were performed.Angiography confirmed that the thrombus in the stent was completely cleared and the blood flow in the stent was normal.Additionally, the hemiparesis and slurred speech were resolved.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

• 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
• MDR Report Key: 11649290
• Report Number: 2024168-2021-03004
• Device Sequence Number: 3367380
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: 07/31/2023
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 0081861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention