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 Myocardial Infarction (1969); Thrombosis (2100)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.There was no reported device malfunction and the products were not returned as the stents remain implanted.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of, thrombosis and myocardial infarction are listed in the xience v coronary stent systems instructions for use, as known patient effects of coronary procedures.A conclusive cause for the reported thrombosis and myocardial infarction, 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.Article: abluminal groove-filled biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent: 3-year results of the target all comers trialna.

Event Description

This is filed to report serious injuries: it was reported through a research article identifying the xience stent that may be related to the following: death, myocardial infarction, stent thrombosis, target lesion revascularization.Details are listed in the attached article, abluminal groove-filled biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent: 3-year results of the target all comers trial.Please see article for additional information.

• 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: 10570274
• MDR Text Key: 208325078
• Report Number: 2024168-2020-07917
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability