MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE V

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

The patient deaths will be filed under a separate medwatch report #.The device was not returned for evaluation.The reported patient effect(s) of myocardial infarction and thrombosis are listed in the xience v everolimus eluting coronary stent systems instructions for use, as a known patient effect(s) of coronary stenting procedures.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.A conclusive cause for the reported patient effect(s) of myocardial infarction, thrombosis, hemorrhage, neurological deficit 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 udi is unknown because the part and lot #s were not provided.Title: the hypercholesterolemia paradox in percutaneous coronary intervention: an analysis of a multicenter pci registryna.

Event Description

It was reported through a research article identifying xience v that may be related to the following: patient death, thrombosis, myocardial infarction, hemorrhage, neurological deficit.This article summarizes clinical outcomes of 1866 patients that were treated with xience v stents.Specific patient information is documented as unknown.Details are listed in the article, titled "the hypercholesterolemia paradox in percutaneous coronary intervention: an analysis of a multicenter pci registry.".

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na - attachment: [article e-22146 cn-025820].

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9848590
• MDR Text Key: 183956245
• Report Number: 2024168-2020-02591
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR