Amplatzer Talisman Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Septal Occluder (ASD/PFO) · First cleared Dec 2017 · 4 device variants grouped
Total Reports
430
Reports (30d)
7
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Left Disc Deformation During Implant
amplatzer septal, chosen implant, amplatzer, occluder chosen, chosen
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Clinical Investigation of the Safety and Effectiveness of the Occlutech Flex II PFO Occluder: Design and Rationale of the Multicenter, Randomized OCCLUFLEX Trial
Andrew Michael Goldsweig, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2025
Platypnea-Orthodeoxia After TAVI for Severe Aortic Regurgitation
Sabrina Kopp, et al. · JACC Case Reports · 2026
Transcatheter Valve-in-Valve Implantation and PFO Closure for Acute Leaflet Thrombosis After Transcatheter Tricuspid Valve Replacement
Rea Ganatra, et al. · JACC Case Reports · 2026
Citations indexed from PubMed.
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