Resolute Integrity Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Feb 2012
Total Reports
1,774
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Resistance During Delivery
coronary drug, issues, negative prep, prep, device inspected
4
reports
Dislodged Stent from Balloon
onyx frontier, coronary drug, frontier coronary, onyx, issues
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Three contemporary thin‐strut drug‐eluting stents implanted in severely calcified coronary lesions of participants in a randomized all‐comers trial
Rosaly A. Buiten, et al. · Catheterization and Cardiovascular Interventions · 2020
Three-year clinical outcome of biodegradable hybrid polymer Orsiro sirolimus-eluting stent and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent: A randomized controlled trial.
Kim SH, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2019
Final 5‐Year Report of the Randomized BIO‐RESORT Trial Comparing 3 Contemporary Drug‐Eluting Stents in All‐Comers
Eline H. Ploumen, et al. · Journal of the American Heart Association · 2022
Comparison of the Major Clinical Outcomes for the Use of Endeavor<sup>®</sup> and Resolute Integrity<sup>®</sup> Zotarolimus-Eluting Stents During a Three-Year Follow-up
Yong Hoon Kim, et al. · Global Heart · 2020
Three-year clinical outcomes between Endeavor Resolute® and Resolute Integrity® Zotarolimus-Eluting Stents in an Asian population
Yong Hoon Kim · The Anatolian Journal of Cardiology · 2020
Citations indexed from PubMed.
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