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

Catalog Number 82086-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Pain (1994)

Event Date 10/03/2019

Event Type  Injury  

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 (b)(4).

Event 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
• Type of Device: 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: 9239746
• MDR Text Key: 164285695
• Report Number: 2024168-2019-12961
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 82086-01
• Device Lot Number: 8121261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 77