ABBOTT (ST. JUDE MEDICAL) · Transcatheter Septal Occluder (ASD/PFO) · First cleared Apr 2010
Total Reports
884
Reports (30d)
14
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Post-Implant Cardiac Tamponade
corresponding mail, included study, patients, ventricular septal, included
22
reports
Literature Batch: PFO Closure Long-Term Outcomes
pfo closure, pfo, included study, patients, included
21
reports
Cobra Deformation with Procedure Aborted
implant using, cobra, deformed, occluder chosen, chosen
7
reports
Device Deformation During Preparation
pfo, talisman, amplatzer talisman, pfo occluder, talisman pfo
4
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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