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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 Insufficient Information (3190)
Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Event Date 03/07/2020
Event Type  Injury  
Manufacturer Narrative
Journal article: efficacy of zotarolimus-eluting stents in treating diabetic coronary lesions: an optical coherance tomography study authors: zhengbin zhu, jinzhou zhu, run du, haotian zhang, jinwei nid journal: advances in therapy year: 2020 ref: doi. Org/10. 6084/m9. Figshare. 11871414. Majority gender,: average age, date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
This study was a single-center subgroup data analysis of the resolute (b)(6) study. The study using optical coherence tomography (oct) aimed to compare target lesion neointima in patients with or without diabetes after zotarolimus-eluting stent (zes) treatment. Oct images of 90,212 struts and quantitative coronary angiography (qca) in 62 patients (32 with dm and 30 without dm) with 69 de novo coronary lesions (34 dm and 35 non-dm) both after zes implantation and at 12 month angiographic follow-up were recorded. Resolute zotarolimus-eluting stents were implanted in all patients enrolled in this study. All patients enrolled took aspirin and clopidogrel after stenting and received monthly clinical follow-up. Clinical outcomes included tlr and non-fatal myocardial infarction. It was reported that neointimal proliferation and neovascularization were more frequently observed in patients with dm than patients without dm. There was no significant difference in late lumen loss between the two groups. Uncovered struts,malapposition, and thrombus were also reported in both groups, at similar rates and the rates were noted to be quite low in both groups. It was stated that the intrastent microthrombus occurrence rate observed by oct was also similar between both groups and no clinical st (stent thrombosis) events were observed. It was also mentioned in relation to another study that a ¿¿catch-up¿¿ phenomenon had been reported which showed that the superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up with respect to occurrence of st was lost after 5 years.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key10886221
MDR Text Key217723977
Report Number9612164-2020-04563
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
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 Received10/28/2020
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: 11/23/2020 Patient Sequence Number: 1
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