Model Number 9-ASD-MF-035 |
Device Problems
Material Deformation (2976); Activation Failure (3270)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results, method, and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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On (b)(6) 2020, a 35 mm amplatzer cribriform occluder was selected for implant.While attempting to implant the device there was a deployment failure.While doing a test deployment on the device, the occluder was found to be deformed.The device was removed and replaced with a 30 mm amplatzer cribriform occluder to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable with no adverse consequences.
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Manufacturer Narrative
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The reported event of a deformed 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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