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

Catalog Number UNK XIENCE V

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 05/01/2020

Event Type  Injury  

Event Description

This report is filed for all adverse events except death it was reported through an article from china: a total of 2,655 patients undergoing percutaneous coronary intervention (pci) were included and divided into two groups according to the type of stent: zes group (n = 1,637) and ees group (n = 1,018).The primary endpoint at 2-year follow-up was major adverse cardiovascular events (mace), including death, non-fatal myocardial infarction, and target vessel revascularization.According to the type of stent implanted: zes group (endeavor resolute stent, medtronic, usa; n = 1,637) and ees group (xience v stent, abbott, usa; n = 1,018).Patients implanted with an ees (everolimus-eluting stent) had a mace of 4.9%, death of 0.5%, non-fatal myocardial infarction of 1.2%, stroke of 1.6%, repeat revascularization of 6.7%, stent thrombosis of 0.6%, and bleeding of 7.3%.

Manufacturer Narrative

Date of event ¿ estimated (b)(6) 2020.Treatment/therapy start date - estimated (b)(6) 2017.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated (b)(6) 2017.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 numbers were not provided.The reported patient effects of myocardial infarction, thrombosis/thrombus, cerebrovascular accident, and hemorrhage (bleeding complications) are listed in the xience v everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported myocardial infarction, thrombosis/thrombus, cerebrovascular accident, and hemorrhage, and their relationship to the product, if any, cannot be determined; however, the subsequent unexpected medical intervention 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 patient effect of death reported and the article is captured under a separate medwatch report.

• 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: 14961297
• MDR Text Key: 295595776
• Report Number: 2024168-2022-07400
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention