Orsiro Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Coronary Drug-Eluting Stent · First cleared Sep 2024 · 27 device variants grouped

Total Reports

2,302

Reports (30d)

25

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Stent Unable to Cross Lesion

stent selected, mission, mission drug, orsiro mission, orsiro

43

reports

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

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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.