MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY 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 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Average age, majority gender, date of publication journal article title: proximal lad treated with thin-strut new-generation drug-eluting stents literature reference: doi.Org/10.1016/j.Jcin.2019.11.018.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this post hoc analysis of patient-level data from 3 randomized clinical trials is to assess 2-year clinical outcome follo wing percutaneous coronary intervention (pci) with thin-strut new-generation drug-eluting stents (des) in patients treated in proximal left anterior descending artery (p-lad) versus non¿p-lad lesions.The study included 6,037 patients without previous bypass surgery or left main stem involvement from the twente i, ii, and iii randomized trials.A total of 1,607 patients had at least 1 des implanted in p-lad and were compared with 4,430 patients who were exclusively treated in other (non¿p-lad) segments.Two-year follow-up was available in 5,995 patients.Data from all trial participants, except for those who were stented for left main disease or previously had cabg, were analysed.Endeavor resolute and resolute integrity were among a number of stents implanted in the study population.It was stated that generally, dual-antiplatelet therapy was prescribed for 6 to 12 months.The study assessed 2 main composite clinical endpoints: the patient-oriented composite endpoint (poce) (any death, any myocardial in farction [mi], or any repeat revascularization) and the device-oriented composite endpoint target lesion failure (tlf) (cardiac death, target vessel mi, or target lesion revascularization).Clinical outcomes included all-cause deaths, cardiac deaths, target vessel myocardial infarction, any repeat revascularization including target lesion revascularization and definite or probable stent thrombosis.

• Brand Name: RESOLUTE INTEGRITY 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: 9985571
• MDR Text Key: 189902867
• Report Number: 9612164-2020-01647
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110013
• 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: 04/22/2020

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: 04/15/2020
• Initial Date FDA Received: 04/22/2020
• 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: 63 YR