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

Catalog Number UNK RX SIERRA

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Death  

Manufacturer Narrative

Date of event, implant date: estimated dates.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effect of death is listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect of 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 additional adverse events referenced are being filed under a separate medwatch report number.The udi is unknown because the part number and lot number were not provided.

Event Description

This study investigated outcomes of bleeding and ischemic events in elderly patients treated with an antithrombotic strategy guided by the estimation of bleeding and ischemic risks after revascularization with xience sierra stents.Primary endpoint was target lesion revascularization and coprimary safety endpoints were a composite of cardiac death, myocardial infarction, and stent thrombosis; and bleeding.Results indicated primary endpoint was 1.5% and safety endpoints were met at 6.2 and 7.8% respectively.Compared with the control group bleeding was significantly lower and it was concluded that in the elderly population the application of this antithrombotic strategy seems to be associated with an improved prognosis.Details are listed in the attached article, titled "tct-265 prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with last generation of everolimus-eluting stents: the sierra-75 (epic-05) registry.".

• Brand Name: XIENCE SIERRA 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: 12824569
• MDR Text Key: 280865841
• Report Number: 2024168-2021-10445
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P110019
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX SIERRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• 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): Death
• Patient Age: 80 YR
• Patient Sex: Male