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

Catalog Number UNK XACT

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Tissue Damage (2104); Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated.The udi is unknown as individual part and lot numbers were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.In this case, there was no reported device malfunction associated with the xact.The reported patient effects of stenosis, vessel damage, myocardial infarction (mi), stroke, and transient ischemic attack (tia) are listed in the xact instructions for use as known possible adverse events that may be associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effects of stenosis, vessel damage, mi, stroke, and tia, 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.The patient effect of death referenced is being filed under a separate medwatch report number.Reported attached: ¿vascular quality initiative, medical device report prepared for abbott vascular, x.Act carotid stent system.¿.

Event Description

It was reported through a post-market clinical follow-up (pmcf) report that the xact carotid artery stent may be related to stroke, mi, access site complication, post-procedural tia, recurrent carotid restenosis, re-treatment (percutaneous and surgical), and death.A device malfunction was not reported.Specific patient information is documented as unknown.Details are provided in the attached pmcf report, vascular quality initiative, medical device report prepared for abbott vascular, x.Act carotid stent system.

• Brand Name: XACT CAROTID STENT SYSTEM
• 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: 11135645
• MDR Text Key: 225808200
• Report Number: 2024168-2021-00245
• Device Sequence Number: 1
• Product Code: NIM
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XACT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR