MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR 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 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Literature reference: 10.1016/j.Jacc.2019.11.058.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to assess the frequency and predictors of very late stent-related adverse events by stent type more than one year after percutaneous coronary intervention.The dataset consisted of 25,032 patients from 19 trials; 3,718 (14.9%), 7,934 (31.7%), and 13,380 (53.5%) patients were treated with bare metal stents (bms), first generation drug-eluting stents (des1), second generation drug-eluting stents (des2), respectively.Medtronic stents implanted included endeavor, resolute integrity and endeavor resolute stents.Patients implanted with des2 were assessed within one year and for a median duration of 4.1 years post stent implantation.Clinical outcomes reported in the study population included all cause death, cardiac death, target vessel myocardial infarction (mi) and non-target vessel mi, stent thrombosis and target vessel revascularization and non-tvr.Data confirmed that des2 were associated with lower rates of very-late major adverse cardiac events (mace), target lesion failure, mi, and stent thrombosis compared with des1.

• Brand Name: ENDEAVOR 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: 9779878
• MDR Text Key: 189305112
• Report Number: 9612164-2020-00976
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/03/2020
• 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: 62 YR