Model Number 9-ASD-010 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020, a 10mm amplatzer septal occluder was selected for a procedure.During procedure, the disc formed cobra shape in the left atrium.The procedure was completed successfully by implanting a new 11mm amplatzer septal occluder.The patient is stable.
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Manufacturer Narrative
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The reported event of a deformity upon deployment not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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