Model Number 9-ASD-MF-030 |
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 05/20/2020 |
Event Type
Injury
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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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Event Description
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On (b)(6) 2020, a 30mm amplatzer cribriform occluder was selected for implant.During the patient and once inside the patient, the device was observed to be distorted when opened on the left atrium side.The device was removed and a new 30 mm amplatzer pfo occluder was successfully implanted.No patient consequences were reported.
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Manufacturer Narrative
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The reported event of a deformed, 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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