XIENCE ALPINE Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Sep 2016
Total Reports
881
Reports (30d)
9
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Distal Edge Dissection Post-Implant
additional information, information provided, skypoint, xience skypoint, provided procedure
12
reports
Polymer-Free Stent Safety Outcomes
outcomes, polymer, article, patients, years
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Standardized bench test evaluation of coronary stents: Biomechanical characteristics.
Bonin M, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2018
Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test
Chang‐Hwan Yoon, et al. · Korean Circulation Journal · 2022
Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
Kyung Hoon Cho, et al. · Journal of Korean Medical Science · 2021
Comparison of coronary angioscopic findings 8 months after stent implantation between two kinds of biodegradable polymer-coated and one durable polymer-coated drug-eluting stent
Keisuke Yasumura, et al. · Coronary Artery Disease · 2020
Comparison between drug-coated balloons and drug-eluting stents in very small coronary artery interventions
Cheng‐Hsuan Tsai, et al. · Scientific Reports · 2022
Citations indexed from PubMed.
Keep exploring
Related devices in Coronary
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,635 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,655 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,082 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,727 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 6,095 reports
Resolute Onyx
MEDTRONIC, INC. · 4,494 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data