The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
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device- or procedure related SAE rate
Timeframe: up to 30 Days
PE, DVT and ischemic stroke and atrial fibrillation rate
Timeframe: beyond 30 days through 3 years
Effective PFO closure
Timeframe: At 1 year