Orsiro Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Coronary Drug-Eluting Stent · First cleared Sep 2024

Total Reports

1,740

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Crossing Difficulty in Severely Calcified Lesion

stent selected, mission drug, stenosis degree, orsiro mission, orsiro

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 trendmediumDisproportionate reportinghigh

Evidence

Related research

Long-Term Outcomes After Percutaneous Coronary Intervention With the Polymer-Free Biolimus-Coated BioFreedom Stent Versus the Biodegradable-Polymer Sirolimus-Eluting Orsiro Stent in Patients With Acute Coronary Syndromes.

Noori M, et al. · 2026

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial

Lars Jakobsen, et al. · EuroIntervention · 2023

BioMatrix versus Orsiro biodegradable polymer stents in all-comer patients with coronary artery disease: the multicentre, randomised BIODEGRADE trial

Chang‐Hwan Yoon, et al. · EuroIntervention · 2021

Safety and Efficacy of Two Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents in Real-World Practice: Genoss DES Stents Versus Orsiro Stents From a Prospective Registry.

Jeon HS, et al. · 2024

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention

Lisette Okkels Jensen, et al. · Circulation · 2020

Citations indexed from PubMed.

Keep exploring

Related devices in Coronary

Perclose ProGlide

ABBOTT VASCULAR INC. · 24,504 reports

→

Perclose ProStyle

ABBOTT VASCULAR INC. · 19,336 reports

→

PERCLOSE

ABBOTT VASCULAR INC. · 9,890 reports

→

Angio-Seal

TERUMO MEDICAL CORPORATION · 6,417 reports

→

SYNERGY

BOSTON SCIENTIFIC CORPORATION · 5,991 reports

→

Resolute Onyx

MEDTRONIC, INC. · 4,467 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. 2 active signals detected right now.

Get Early Access

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.

→

How a safety signal is detected

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

→

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.