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 Stroke/CVA (1770); Myocardial Infarction (1969); Thrombus (2101); Injury (2348); Blood Loss (2597)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Lit ref: 10.1253/circj.Cj-19-0667.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to evaluate the safety and efficacy of guideline-recommended risk score-directed dual antiplatelet therapy (gd-dapt) based on the precise-dapt score after 2nd-generation drug-eluting stent (des) implantation.Data of 5,131 patients pooled from 4 random study populations who were treated with 2nd-generation des were included in the final study population.The four randomised studies patient data was pooled from were the ivus-xpl, reset, optima-c and excellent trials.2,117 patients included in the reset trial were treated with a resolute zotarolimus des or a endeavor zotarolimus des.Patients were divided into 3 groups according to current recommendations on the duration of dapt and their actual dapt duration.A ll three of these groups consisted of a number of patients implanted with a endeavor zotarolimus des.Patients implanted with resolute zotarolimus des were included in the gd-dapt and longer dapt groups but not the shorter dapt group.The primary endpoint was the rate of net adverse clinical events (nace) during the first 12 months.The secondary endpoints were ischemic or bleeding events.Nace comprised of cardiac death, myocardial infarction (mi), st, stroke, or major bleeding during the first 12 months.Clinical outcomes in the study population included cardiac death, myocardial infarction (mi), stent thrombosis (st), stroke, bleeding and ischemia-driven target vessel revascularization (tvr).

• 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: 9871093
• MDR Text Key: 189720128
• Report Number: 9612164-2020-01323
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/24/2020

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: 03/16/2020
• Initial Date FDA Received: 03/24/2020
• 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