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 Arrhythmia (1721); Stroke/CVA (1770); Headache (1880); Liver Damage/Dysfunction (1954); Myocardial Infarction (1969); Swelling (2091); Thrombus (2101); Dizziness (2194); Reaction (2414); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Add'l info: (b)(4).Medical devices: clopidogrel and cilostazol journal article: title: comparison of 1-year outcomes of triple (aspirin+clopidogrel+cilostazol) versus dual antiplatelet therapy (aspirin+clopidogrel+placebo) after implantation of second-generation drug-eluting stents into one or more coronary arteries.Journal: the american journal of cardiology issue: 4 ref: doi.Org/10.1016/j.Amjcard.2017.1.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted that documented a study which sought to evaluate the impact of triple antiplatelet therapy on clinical outcomes in patients treated with second-generation drug-eluting stents (des) for coronary artery disease.404 patients were enrolled in the study and divided in to two groups of 202 each, those who were treated with second-generation des and triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol) and those who were treated with des and dual antiplatelet therapy (aspirin, clopidogrel, and placebo).The clinical presentations of the study participants were stable angina, unstable angina and acute mi.95 zotarolimus eluting stents were among the 530 des stents implanted.Lesions treated were the lad, left cx, right, ramus intermedius.Clinical outcomes after one year included death due to mi, ischemic stroke and ischemic-driven tvr.Other clinical outcomes reported were peri-procedural myocardial infarction, ischemic stroke, ischemic-driven target vessel revascularization and stent thrombosis.It was further reported that the following adverse effects occurred due to use of drugs; bleeding, neutropenia, hepatic dysfunction , headache, dizziness, gastrointestinal trouble, allergic reaction, peripheral edema and palpitation.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8231450
• MDR Text Key: 132526132
• Report Number: 9612164-2019-00136
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• 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: 12/10/2018
• 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
• Treatment: STATIN, BETA BLOCKER, ACEI/ARB, ASPIRIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR