XIENCE Sierra Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Oct 2020

Total Reports

889

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Distal Edge Dissection Post-Implant

additional information, information provided, skypoint, xience skypoint, provided procedure

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Increasing trendcritical

Evidence

Related research

Device profile of the XIENCE V and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy

Andreas Mitsis, et al. · Expert Review of Medical Devices · 2020

Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk

Daphne van Vliet, et al. · European Heart Journal Open · 2025

Comparison of overexpansion capabilities and thrombogenicity at the side branch ostia after implantation of four different drug eluting stents

Paweł Gąsior, et al. · Scientific Reports · 2020

Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial

Robbert J. de Winter, et al. · EuroIntervention · 2022

Evolution of Coronary Stent Platforms: A Brief Overview of Currently Used Drug-Eluting Stents

Pierre Brami, et al. · Journal of Clinical Medicine · 2023

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.