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

Catalog Number	82086-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Pain (1994)
Date of Event	10/03/2019
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.The reported patient effects of pain and stroke are listed in the xact instructions for use as known potential patients effect potentially associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported that the procedure was to treat a carotid artery.A xact carotid stent system was used for this procedure and deployed without issue following the instructions for use (ifu).An unspecified balloon was used for standard post-dilatation of the lesion.However the patient started to feel discomfort.At this point, the filter was retrieved and neurological, visual, and verbal tests were done.It was noted that the patient's left eye drooped and vision changes occurred, when the patient smiled the face started to droop, speech was slurred; the patient had a stroke.Tissue plasminogen activator medication was provided to the patient immediately.There is no determination on what caused the stroke.Patient is doing well and recovered.No additional information was provided.

• Brand Name: XACT CAROTID
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9239746
• Report Number: 2024168-2019-12961
• Device Sequence Number: 16547109
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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: 11/30/2021
• Device Catalogue Number: 82086-01
• Device Lot Number: 8121261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/25/2019
• 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; Disability
• Patient Age: 63 YR
• Patient Weight: 77