Orsiro Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Coronary Drug-Eluting Stent · First cleared Sep 2024
Total Reports
1,223
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Inability to Cross Severely Calcified Lesion
stent selected, mission drug, orsiro mission, orsiro, affected device
9
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Keep exploring
Related devices in Coronary
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,591 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,487 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,006 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,574 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 6,056 reports
Resolute Onyx
MEDTRONIC, INC. · 4,478 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data