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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
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.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, 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 Key8231450
MDR Text Key132526132
Report Number9612164-2019-00136
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/09/2019 Patient Sequence Number: 1
Treatment
STATIN, BETA BLOCKER, ACEI/ARB, ASPIRIN.
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