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

Catalog Number UNK RX XIENCE

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 04/23/2014

Event Type  Injury  

Manufacturer Narrative

Estimated date of event.The udi # is unknown because the part number and lot number were not provided.Estimated date of implant.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.A conclusive cause for the reported thrombosis, myocardial infarction and hemorrhage and the relationship to the product, if any, cannot be determined.The reported patient effects of thrombosis and myocardial infarction are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The patient deaths are being filed under a separate medwatch report number.Literature: comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresorbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the century ii randomized clinical trial.(b)(4).

Event Description

It was reported through a research article identifying that xience stents may be related to the following: myocardial infarction, stent-thrombosis, bleeding, death, rehospitalization and revascularization.This article summarizes clinical outcomes of 231 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the article, titled "comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresorbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the century ii randomized clinical trial.".

• Brand Name: XIENCE V 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: 10488166
• MDR Text Key: 205499581
• Report Number: 2024168-2020-07337
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR