XIENCE V Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Aug 2011

Total Reports

940

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.

Evidence

Related research

A clinical evaluation of the XIENCE V everolimus eluting stent in the treatment of patients with coronary artery disease: Result from Thailand Registry - XIENCE V performance evaluation (THRIVE study).

Kiatchoosakun S, et al. · Indian heart journal · 2016

Four-Year Outcomes of Multivessel Percutaneous Coronary Intervention With Xience V Everolimus-Eluting Stents.

Lee MS, et al. · The Journal of invasive cardiology · 2019

Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry

You‐Jeong Ki, et al. · Journal of Interventional Cardiology · 2020

Long‐Term Clinical Outcomes of Biodegradable‐ Versus Durable‐Polymer‐Coated Everolimus‐Eluting Stents in Real‐World Post‐Marketing Study

Waiel Abusnina, et al. · Catheterization and Cardiovascular Interventions · 2024

3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation

Roxana Mehran, et al. · JACC: Cardiovascular Interventions · 2021

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.