MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RX; STENT, CORONARY, DRUG-ELUTING

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

Patient Problems Embolism (1829); Myocardial Infarction (1969); Occlusion (1984); Perforation (2001); Thrombosis (2100); Stenosis (2263); Injury (2348); Vascular Dissection (3160)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of publication.Journal article title: randomized comparison of everolimus- and zotarolimus-eluting coronary stents with biolimus-eluting stents in all-comer patients literature reference: 10.1161/circinterventions.119.008525.If information is provided in the future, a supplemental report will be issued.

Event Description

This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either non-medtronic evero limus-eluting stent (ees) and the resolute zotarolimus-eluting stent (zes) with the non-medtronic biolimus-eluting stent (bes).In a 1:1:1 ratio in 15 centers across (b)(6).Patients were enrolled from january 2013 to december 2015.Patients with stable coronary artery disease or acute coronary syndrome including st-segment¿elevation mi were eligible if at least 1 coronary artery had significant stenosis.Any event of a slow/noreflow phenomenon, side branch occlusion, distal embolization, edge dissection, flow-limiting dissection, perforation, or acute closure during the procedure was counted as a procedural complication.A total of 1911 patients (638 patients in ees; 634 patients in bes; and 639 patients in zes) were assessed for the primary end point.Vessels treated included the left anterior descending, left circumflex, left main and right coronary artery.24-month clinical outcomes (including in the zes group) included a device-oriented composite outcome consisting of cardiac death, ta rget-vessel myocardial infarction, and clinically indicated target lesion revascularization.Secondary outcomes included a patient-oriented composite outcome consisting of any death, any mi, and any revascularization.Stent thrombosis was also reported.

Manufacturer Narrative

It was confirmed that there was no cardiac death related to stents.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDEAVOR RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10013032
• MDR Text Key: 196915330
• Report Number: 9612164-2020-01723
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR