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

Catalog Number UNK XIENCE

Device Problem Insufficient Information (3190)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 08/01/2014

Event Type  Injury  

Manufacturer Narrative

Estimate date of event. Estimated date of implant. The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The malfunctions referenced are being filed under a separate medwatch report number. The additional absorb device referenced is being filed under a separate medwatch report number. Literature: the relationship of pre-procedural dmax based sizing to lesion level outcomes in absorb bvs and xience ees treated patients in the aida trial.

Event Description

It was reported through a research presentation identifying absorb bvs and xience stents that may be related to the following: myocardial infarction, thrombosis, revascularization, rehospitalization. Deployment difficulty was also noted for both absorb bvs and xience stents. This article summarizes clinical outcomes of 1,845 patients that were treated with xience stents. Specific patient information is documented as unknown. Details are listed in the article, titled "the relationship of pre-procedural dmax based sizing to lesion level outcomes in absorb bvs and xience ees treated patients in the aida trial. ".

• 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: 10780326
• MDR Text Key: 214428296
• Report Number: 2024168-2020-09192
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/03/2020 Patient Sequence Number: 1