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

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

Journal article: durable polymer versus biodegradable polymer drug-eluting stents in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: a post hoc analysis of the host-rp-acs.Year: 2022 ref:doi:10.4244/eij-d-22-00372 a2: average age a3: majority gender b3: date of publication medication: aspirin, clopidogrel, prasugrel, ticagrelor.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; durable polymer versus biodegradable polymer drug-eluting stents in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: a post hoc analysis of the host-reduce-polytech-acs trial.This study sought to evaluate the efficacy and safety of durable polymer drug-eluting stents (dp-des) and biodegradable polymer (bp) des (bp-des), in acs patients receiving complex percutaneous coronary intervention (pci).Medtronic resolute onyx coronary drug eluting stents were amongst a number of stents used in the dp-des group.Complex pci was defined as a high-risk procedure with at least 1 of the following features: =3 stents implanted, =3 lesions treated, bifurcation pci with 2 stents, total stent length =60 mm, left main pci, or heavy calcification.The primary outcome was a patient-oriented composite outcome (poco) at 12 months.The poco was a composite of all-cause death, non-fatal myocardial infarction (mi), and any repeat revascularization.The secondary outcome was a device-oriented composite outcome (doco) at 12 months, including cardiac death, target vessel mi, and target lesion revascularization (tlr).The individual outcomes of the composite outcomes, stent thrombosis, target vessel revascularization (tvr), and non-tvr were also evaluated.Complete procedural data were available in 3,301 patients with 72 patients lost to follow-up.Based on the procedural data, patients were categorized into those who received complex pci (1,140 patients) and those who received non-complex pci (2,161 patients).Among patients in the complex pci group, 675 patients had a total stent length of 60 mm or longer, 518 patients had heavily calcified lesions, 514 patients had 3 or more stents, 259 patients had 3 or more lesions treated, 224 patients underwent bifurcation pci with 2 stents, and 158 patients underwent left main (lm) pci.Lesions being treated included the lm, left anterior descending artery, left circumflex artery, and the right coronary artery.Among patients in the complex pci group, 570 patients were allocated to the dp-des group and 570 patients to the bp-des group.In those who received non-complex pci, 1,088 patients were assigned to the dp-des group and 1,073 patients to the bp-des group.Clinical outcomes at 12 month follow up in both complex and non-complex dp-des groups included poco, doco, all cause death, cardiac death, non-fatal mi, target vessel mi, stent thrombosis, repeat revascularization, tvr, tlr, and non-tvr.Patients who underwent complex pci had a higher risk of poco and doco at 12 months compared to those who underwent non-complex pci.There was no significant difference at 12 months between patients receiving dp-des and bp-des for both complex and non-complex pci groups.

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.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: 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: 18046999
• MDR Text Key: 327060361
• Report Number: 9612164-2023-04963
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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: 11/09/2023
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Male