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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Stroke/CVA (1770); Infarction, Cerebral (1771); Death (1802); Ischemia (1942); Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative
Title: temporal course of vascular healing and neoatherosclerosis after implantation of durable- or biodegradable-polymer drug-eluting stents authors: guagliumi, giulio; guagliumi, giulio; shimamura, kunihiro; sirbu, vasile; garbo, roberto; boccuzzi, giacomo; vassileva, ang elina; valsecchi, orazio; fiocca, luigi; canova, paolo; colombo, francesco; tensol rodriguez pereira, gabriel; nakamura, daisuke; attizzani, guilherme f; cereda, alberto; satogami, keisuke; de luca, leonardo; saia, francesco; capodanno, davide; nlm journal: european heart journal year: 2018 issue: 0, 1-10 ref: https://doi. Org/10. 1093/eurheartj/ehy273. A2
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average, age a3
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majority gender, b3
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date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
This study was to compare in vivo vessel healing and na of current generation bp- or dp-des using serial optical coherence tomography (oct) assessments. Ninety patients were randomised to this study and resolute integrity drug-eluting stent was implanted in fourty-five patients in the study population. Vessels treated were lad, cx and rca. At 3 months, all randomized patients underwent angiographic and oct follow-up. The rates of covered, uncovered, uncovered and apposed struts were comparable between everolimus eluting stents and zotarolimus eluting stents, with some degree of inter-individual variability in both groups. The vast majority of uncovered struts were completely apposed to the vessel wall 85% in both groups. Clinical events reported at 3-months follow-up are myocardial infarction and target vessel revascularization. Clinical events reported at 2 year follow-up are death (non-cardiac), stroke, mi, target lesion revascularization and ischemia-driven target lesion revascularization.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7669606
MDR Text Key113416050
Report Number9612164-2018-01668
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
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 Received08/08/2018
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: 07/09/2018 Patient Sequence Number: 1
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