Model Number 9-ASD-019 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Event Description
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It was reported on (b)(6) 2021, a 19mm amplatzer septal occluder was selected for implant.Upon deployment, a cobra deformation on the distal disc was noted.The device was removed successfully and the patient was refereed to surgical repair.The patient status is recovering.
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Manufacturer Narrative
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The reported event of cobra deformation could 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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