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

Catalog Number UNK XIENCE

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 10/29/2010

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.The udi is unknown because the part number and lot number were not provided.Implant date estimated.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of thrombosis, myocardial infarction, cerebrovascular accident, ischemia and hemorrhage are listed in the xience v and xience nano everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported thrombosis, myocardial infarction, cerebrovascular accident, ischemia and hemorrhage, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The patient deaths mentioned are being filed under a separate medwatch report number.Literature title : everolimus-eluting stents or bypass surgery for left main coronary artery disease.

Event Description

It was reported through a research article identifying that xience stents may be related to the following: death, myocardial infarction, stroke, ischemia, thrombosis, bleeding, revascularization and rehospitalization.This article summarizes clinical outcomes of 1905 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the article, titled "everolimus-eluting stents or bypass surgery for left main coronary artery disease.".

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11322461
• MDR Text Key: 231635438
• Report Number: 2024168-2021-01147
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P070015
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR