Amplatzer Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Septal Occluder (ASD/PFO) · First cleared Apr 2010
Total Reports
962
Reports (30d)
13
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Deployment Failure with Cobra Formation
implant using, cobra, vsd, occluder chosen, chosen
23
reports
Long-Term Stroke Risk Post-PFO Closure
events, pfo closure, long term, stroke transient, embolism
17
reports
Device Slippage with Pericardial Effusion
asd occluder, cardioform asd, gore cardioform, cardioform, cardioform septal
5
reports
Shape Conformity Issue During Implant
talisman, amplatzer talisman, occluder chosen, chosen, talisman pfo
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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