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 Problem Ischemia (1942)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated. The device was not returned for evaluation. A review of the lot history record could not be conducted because the part and lot number was not provided. The reported patient effect of ischemia is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures. A conclusive cause for the reported ischemia, and the relationship to the product, if any, cannot be determined. The treatment(s) 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 additional adverse patient effect of death referenced is being filed under a separate medwatch report number. Article titled: clinical outcome of biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with diabetes.

Event Description

It was reported through a research article identifying xience drug-eluting stents that may be related to the following: ischemia driven target lesion/vessel revascularization and deaths. Details are listed in the article, titled "clinical outcome of biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with diabetes".

• 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: 11426437
• MDR Text Key: 238344909
• Report Number: 2024168-2021-01768
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• 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: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 03/07/2021 Patient Sequence Number: 1