Amplatzer Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Septal Occluder (ASD/PFO) · First cleared Apr 2010
Total Reports
937
Reports (30d)
6
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cobra Deformation During Implantation
trevisio, amplatzer trevisio, amplatzer septal, cobra deformation, trevisio delivery
8
reports
Swollen Disc Prior to Implantation
corresponding, talisman, amplatzer talisman, article, patients
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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