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

Model Number 82090-01

Device Problem Material Separation (1562)

Patient Problems Dizziness (2194); Stenosis (2263)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat an internal carotid artery.The 8x40mm xact stent was implanted on (b)(6) 2019.On (b)(6) 2019, the patient was re-examined due to dizziness.It was then found that the xact stent was separated and the vessel was re-stenosed.The patient is being treated with medication.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 incidents.Cine images were provided and reviewed by an abbott vascular clinical specialist.The review noted the following: there is an obvious fracture of one of the stents in the images provided.A probable cause cannot be determined from the images provided.The reported patient effect of restenosis is listed in the xact instruction for use as a known adverse event potentially associated with carotid stents and embolic protection systems.Based on the information provided, medical review and cine review, a conclusive cause for the reported stent fracture and subsequent patient effects could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XACT CAROTID
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9571958
• MDR Text Key: 178346314
• Report Number: 2024168-2020-00522
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 9041161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80