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 Death (1802); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 09/08/2020

Event Type  Death  

Manufacturer Narrative

Estimated date of death.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.The reported patient effect of death is listed in the xience v and xience nano everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.A conclusive cause for the reported death 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 adverse patient effects mentioned are being filed in a separate medwatch report number.Article: comparison of ultrathin, bioresorbable-polymer sirolimus-eluting stents and thin, durable- polymer everolimus-eluting stents in calcified or small vessel lesions.

Event Description

It was reported through a research article identifying that xience stents may be related to the following: death, myocardial infarction, ischemia, stent-thrombosis, rehospitalization and revascularization.This article summarizes clinical outcomes of 784 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the article, titled "comparison of ultrathin, bioresorbable-polymer sirolimus-eluting stents and thin, durable- polymer everolimus-eluting stents in calcified or small vessel lesions.".

• 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: 11343283
• MDR Text Key: 232376793
• Report Number: 2024168-2021-01288
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR