Orsiro Mission Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Coronary Drug-Eluting Stent · First cleared Sep 2024
Total Reports
632
Reports (30d)
25
Active Signals
2
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
68
reports
Stent Dislodgement During Introduction
dislodgement occurred, patient complications, advanced treatment, synergy drug, stent advanced
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Rescue intracranial stenting for acute large vessel occlusion using an Orsiro Mission drug-eluting balloon-mounted stent
Krishna Amuluru, et al. · Interventional Neuroradiology · 2025
Case report—snare loop retrieval of an unnoticed lost stent after 3 months: the later, the harder
Farhang Aminfar, et al. · European Heart Journal - Case Reports · 2025
Citations indexed from PubMed.
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