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 06/26/2020 |
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 a 25 mm amplatzer cribriform occluder was chosen for a pfo closure procedure.While the implanting physician was attempting the closure, the physician called abbott rep, as the abbott rep was not notified prior.Although the device was not released the abbott rep was called via (b)(6) after its deployment to help ascertain the cause of the left atrial disc becoming misshaped.The physician explained the events as they occurred during before and during deployment.The abbott rep stated that it was difficult to ascertain the cause remotely after device deployment.Based on limited information available, the abbott rep suggested the recapture and retrieval of the 25mm device.The device was recaptured and retrieved without issue.After retrieving the device, the physician examined if device was in fact deformed.The physician confirmed that the left atrial disc was not returning to its proper shape.A new device was recommended, and physician chose to upsize to a 30mm cribiform device, the same deformation occurred.It was at this time the physician chose to remove the device and abort the procedure.The patient remained stable throughout the procedure per the physician.Physician stated that the patient was not impacted.Devices: 25mm cribiform occluder ref: 9-asd-mf-025 lot 6840860 30mm cribiform occluder ref: 9-asd-mf-030 lot: 553314.
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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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Event Description
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On (b)(6) 2020 a 25 mm amplatzer cribriform occluder was chosen for a pfo closure procedure.While the implanting physician was attempting the closure, the physician called abbott rep, as the abbott rep was not notified prior.Although the device was not released the abbott rep was called via facetime after its deployment to help ascertain the cause of the left atrial disc becoming misshaped.The physician explained the events as they occurred during before and during deployment.The abbott rep stated that it was difficult to ascertain the cause remotely after device deployment.Based on limited information available, the abbott rep suggested the recapture and retrieval of the 25mm device.The device was recaptured and retrieved without issue.After retrieving the device, the physician examined if device was in fact deformed.The physician confirmed that the left atrial disc was not returning to its proper shape.A new device was recommended, after attempting with 25mm x2, the physician chose to upsize to a 30mm cribiform device, the same deformation occurred.It was at this time the physician chose to remove the device and abort the procedure.The patient remained stable throughout the procedure per the physician.Physician stated that the patient was not impacted.Devices: 25mm cribiform occluder ref: 9-asd-mf-025 lot 6840860; 9-asd-mf-025 lot: 6928439, 30mm cribiform occluder ref: 9-asd-mf-030 lot: 553314.
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Search Alerts/Recalls
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