Model Number 9-ASD-MF-025 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020, during the positioning of a 25 mm amplatzer cribriform occluder (aco), the left atrial disc assumed an incorrect form - bulbous shape.The device was not implanted and removed from the patient.The aco was attempted to be deployed outside of the patient with no success.A second 25 mm aco was used and implanted successfully using the first delivery system.The patient did not experience any adverse consequences and this event was not attributed to patient anatomy.In the attachment the device picture taken from echo tee.
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Manufacturer Narrative
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The reported event of a round, bulbous deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met 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 defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.
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Search Alerts/Recalls
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