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

Catalog Number UNK-CV-GWY-INT-DES

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

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 03/27/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

This study was conducted to compare the efficacy and safety of the endeavor resolute (r-zes) and resolute integrity (i-zes) zotaroli mus-eluting stents in the all-comer korean patients who underwent percutaneous coronary intervention (pci) during a 3-year follow-up period.In this single-center, retrospective, and all-comer patients¿ cohort study, a total of 889 patients who underwent pci with r-zes (n=394) or i-zes (n=495) between january 2004 and december 2014 at the cardiovascular center of korea university guro hospital, seoul, south korea were enrolled.The primary endpoint was the occurrence of major adverse cardiac events (maces) defined as all-cause death, nonfatal myocardial infarction (mi), any repeat revascularization including target lesion revascularization (tlr), target vessel revascularization (tvr), and non-tvr, and the secondary endpoint was stent thrombosis (st) at 3 years.After stent implantation, dapt (100mg daily aspirin and 75 mg daily clopidogrel) was prescribed at least for 12 months.Clinical outcomes in both groups included all-cause death, cardiac death, nonfatal mi, any repeat revascularization and definite or probable stent thrombosis.All-cause deaths were defined as cardiac (cd) or non-cd.

Manufacturer Narrative

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: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10085214
• MDR Text Key: 192150136
• Report Number: 9612164-2020-01965
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-INT-DES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 64 YR