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

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

Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 03/22/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled "outcomes of patients undergoing pci of ostial coronary lesions: a single-center study.The aim of this single-center, all-comer, prospective registry study was to investigate the outcomes of patients undergoing percutaneous coronary intervention (pci) of ostial lesions compared to proximal non-ostial lesions with the use of contemporary drug eluting stents (des).The outcomes of enrolled patients were analyzed between january 2016 and february 2018.Patients eligible for enrolment were 18 years of age or older, undergoing elective or urgent coronary angiography for st-elevation myocardial infarction, non-st-elevation myocardial infarction, unstable, or stable angina.Patients with proximal obstructive lesions in a main epicardial vessel (left anterior descending artery (lad), left circumflex (lcx), right coronary artery (rca), or ramus intermedius (ram)) requiring pci were included.The study population was divided into two groups and outcomes were compared between those with ostial versus proximal non-ostial lesions.Ostial lesions were defined as lesions located within 3 mm of the ostium of the lad, lcx, ram, or rca.Proximal non-ostial lesions were those located in the proximal segment of the artery, before the first significant side branch in the lad or lcx and before the proximal bend in the rca, without involvement of the ostium.Overall, 1,856 patients were enrolled in the registry, of which 334 patients were included in the present analysis in this article ¿ 91 patients with ostial lesions and 243 with proximal non-ostial lesions.Peri-procedural anticoagulation with heparin and glycoprotein iib/iiia inhibitors was administered according to the local practice.Post-procedural dual antiplatelet therapy was recommended according to current guidelines for a duration of at least 6 months in stable patients and 1 year in acute coronary syndrome patients, unless decided otherwise by the interventional cardiologist, with a single antiplatelet agent continued indefinitely afterward.The pci technique, stent type, and size were left to the discretion of the interventional cardiologist.Des were used in all procedures and included the medtronic resolute onyx des as well as several non-medtronic (mdt) brands of des.Procedural characteristics were also between the groups.The primary endpoint was 1-year target vessel revascularization (tvr), defined as any revascularization procedure within the major epicardial vessel in which the stent was implanted, including its branches.Secondary endpoints included 1-year target lesion revascularization (tlr) and mace.Tlr was defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site, including inside the stent and within 5 mm of the proximal and distal stent margins.Mace was defined as a composite of all-cause mortality, mi, or revascularization.A clinical follow-up was obtained using telephone calls at 1, 6 and 12 months following the procedure and was confirmed using the hospital¿s medical records.A 12-month follow-up was completed in 96% (87/91) and 99% (240/243) of patients in the ostial and proximal non-ostial groups, respectively.One case of a procedural complication of arrhythmia occurred in the non-ostial group and one case of no flow procedural complication occurred in the ostial group.At 1-year following pci, the occurrence of tvr and tlr was numerically higher among patients undergoing pci of ostial versus non-ostial lesions without reaching statistical significance.There was no significant difference between the groups in the rate of mace and other secondary outcomes.Outcomes at 1 month post pci were also similar between groups.Clinical outcomes at 1 year included tvr, tlr, mace, all cause mortality, re-hospitalization, coronary artery bypass graft (cabg), myocardial infarction, pci and stent thrombosis.

Manufacturer Narrative

Title: outcomes of patients undergoing pci of ostial coronary lesions: a single-center study.Authors: lior zornitzkia, aviram hochstadta, itamar loewensteina, johnathan ereza, atalia wenkerta, yonatan moshkovitsa, ella toledanoa, ehud chorina, jeremy ben-shoshana, amir halkina, samuel bazana, yaron arbela, ariel finkelsteina, shmuel banaia, maayan konigstein.Journal name: cardiology year: 2022 reference: doi.Org/10.1159/000524281 pmid: 35358973.Pages: 367-374.A2: average age a3: majority gender b3: date of publication 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.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.

Manufacturer Narrative

Additional information: annex d code.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 ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 18483862
• MDR Text Key: 332554411
• Report Number: 9612164-2024-00190
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 02/12/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male