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

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Date of event: date of publication journal article title:prognostic significance of the medina classification in bifurcation lesion percutaneous coronary intervention with second-generation drug-eluting stents heart and vessels (2020) 35:331¿339 https://doi.Org/10.1007/s00380-019-01504-z.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to assess the prognostic significance of the medina classification following percutaneous coronary intervention (pci) by examining whether tb (true bifurcation) lesion pci confer worse prognosis than ntb (non-true bifurcation) lesion pci, both in the short- and the long-term outcomes.The rates of death and major adverse cardiac events were assessed at 12 months and 3 years follow-up.Final analysis was performed only on patients who had undergone pci with second-generation des and were characterized according to the medina classification.505 patients treated with second-generation drug-eluting stents (des) between the years 2003 and 2015 were included in this prospective registry.Endeavor resolute, resolute integrity and resolute onyx stents along with 5 other second-generation des non-medtronic stents were implanted in patients in this registry.The resolute and endeavour devices were implanted in patients from both the tb (true bifurcation) lesion pci and ntb (non-true bifurcation) lesion pci groups.Oral clopidogrel, prasugrel, or ticagrelor were prescribed to patients for at least 6 months post-procedure.Clinical outcomes included all-cause death, cardiac death, acute myocardial infarction, stent thrombosis, coronary artery bypass grafting surgery and target lesion revascularisation.

• 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: 9896731
• MDR Text Key: 196551819
• Report Number: 9612164-2020-01390
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• 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: 03/16/2020
• 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): Required Intervention
• Patient Age: 64 YR