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

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 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: relative impact of clinical risk versus procedural risk on clinical outcomes after percutaneous coronary intervention authors: jeehoon kang, kyung woo park, hak seung lee, chengbin zheng, tae-min rhee, you-jeong ki, mineok chang, jung-kyu han, han-mo yang, hyun-jae kang, md; bon-kwon journal: circulation: cardiovascular interventions year: 2021.Reference: doi: 10.1161/circinterventions.120.00964.Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.Average age.Majority gender.Date of publication 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.

Event Description

A journal article was submitted for review titled: relative impact of clinical risk versus procedural risk on clinical outcomes after percutaneous coronary intervention.The aim of this study was to evaluate the relative importance of clinical and procedure factors on clinical outcomes using a nationwide prospective registry of patients undergoing percutaneous coronary intervention (pci) with second-generation drug eluting stents (des).The grand des registry is a pooled database of 5 nationwide prospective registries from korea of patients receiving pci with des for coronary artery disease (cad).Host-resolinte and resolute-korea were two registries included which used resolute integrity stents.The total number of patients from all the registries was 17,286 of which 13,172 received a second generation des.The population was grouped into high, intermediate and low risk according to the number of clinical and procedural risk factors.Clinical follow up was performed for 3 years.The primary outcomes were major adverse cardiac and cerebrovascular events (macces - a composite of all cause death, any myocardial infarction (mi), stent thrombosis and ischemic stroke).The secondary end points were clinically significant bleeding events and thromboembolic events at 3 years.Lesions treated included lesions that were calcified, tortuous, had thrombus in the lesion and had been previously treated.During the follow-up period macce occurred in 1109 (8.4%) of the patients and bleeding events occurred in 364 (2.8%) of patients.Adverse events reported included: all cause death, cardiac death, mi, target vessel mi, any revascularization, clinically driven target lesion revascularization (tlr), stent thrombosis, ischemic stroke, hemorrhagic stroke, minor bleeding and major bleeding.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15063522
• MDR Text Key: 296213903
• Report Number: 9612164-2022-02743
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male