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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

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.The reported patient effects of transient ischemic attack, hypotension, stenosis, and bradycardia are listed in the xact instructions for use as known possible adverse events that may be associated with carotid stents.Based on the case information, a conclusive cause for the reported patient effects of tia- transient ischemic attack, hypotension, stenosis and bradycardia, and the relationship to the product, if any, cannot be determined.The reported hospitalization was likely due to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The patient death referenced is being filed under a separate medwatch report #.The udi number is unknown as the part and lot #s were not provided.Article titled, 'carotid artery stenting vs.Carotid endarterectomy: a comparative non-randomized study in two university hospitals.'.

Event Description

It was reported through a research article identifying the xact carotid artery stent that may be related to death, transient ischemic attack, hypotension, restenosis, and bradycardia.Specific patient information is documented as unknown.Details are listed in the article, carotid artery stenting vs.Carotid endarterectomy: a comparative non-randomized study in two university hospitals.

• 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: 11057087
• MDR Text Key: 223184884
• Report Number: 2024168-2020-10835
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 12/08/2020
• 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