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 Stroke/CVA (1770); Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: long-term outcomes of biodegradable versus second-generation durable polymer drug-eluting stent implantations for m yocardial infarction authors: jeong cheon choe, kwang soo cha, jeong gyu lee et.Al.Journal: jacc: cardiovascular interventions year: 2020 reference: doi.Org/10.1016/j.Jcin.2019.08.020 there is no established or suspected causal relationship between the device and the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.Average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted.The aim of the study was to compare long-term outcomes of patients with acute myocardial infarction who underwent pci with bp-des (biodegradable polymer drug-eluting stent) or second-generation dp-des (durable polymer drug-eluting stent).10443 patients were included in the study. resolute onyx rx and resolute integrity rx coronary zotarolimus-eluting stents were implanted in 2559 patients within the second-generation dp-des group of the population.The remaining patients within the second-generation dp-des group were implanted with two other non-medtronic dess.All patients were followed up by their clinicians regularly (1- to 3-month intervals).Clinical outcomes reported in the study population included all cause-deaths including cardiac deaths, recurrent myocardial infarction, heart failure requiring re-admission, stroke, revascularization with repeat pci and cabg, and definite or probable stent thrombosis.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9691739
• MDR Text Key: 189005486
• Report Number: 9612164-2020-00656
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/11/2020
• 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: 64 YR