MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)
Total Reports
104
Reports (30d)
7
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Literature Batch: TAVR Outcomes
devices, evolut, patients, study, included
8
reports
Delivery Catheter Positioning Issues
deployment, dcs, catheter dcs, balloon, delivery catheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
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