Model Number 505DA22 |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/22/2024 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that during the implant of this 22mm aortic mechanical valve, it was explanted and replaced with a valve of the same model and size.The reason for the replacement was reported as a stuck valve leaflet.It was stated that one side of the valve leaflet was inflexible during implantation and that after re-adjusting the position, one side of the valve leaflet was still inflexible.The valve was replaced and there was no impact on the patient. no additional adverse patient effects were reported.
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Event Description
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Additional information was received that no impingement was noted, the leaflet motion was tested with the blue actuator during the implant procedure and the valve rotated within the annulus in attempt to obtain appropriate leaflet motion.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that changed the event description of this previously reported event.Updated: b5 corrected: h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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