BIOTRONIK SE & Co. KG · Coronary Drug-Eluting Stent · First cleared Sep 2024
Total Reports
583
Reports (30d)
27
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Inability to Cross Severely Calcified Lesion
stent selected, mission, mission drug, orsiro mission, orsiro
53
reports
Shaft Break During Withdrawal
synergy, lesion located, shaft, completed, synergy drug
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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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.
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