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Model Number FR99525 |
Device Problems
Incomplete Coaptation (2507); Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
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Event Date 01/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that 15 years and 5 months post implant of this 25mm aortic bioprosthetic valve, it was explanted and replaced with a valve of the same size and model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received additional information that reported the reason for replacement as a large 3.5cm diameter pseudoaneurysm at the distal suture line of the bioprosthetic valve to the ascending aorta.There was also trace regurgitation of the valve with restrictive leaflet mobility of the right and left leaflets.It was also reported that there was aneurysmal dilation of the root of the bioprosthetic valve into the right coronary sinus.It was stated that there was fibrinous pannus on the aortic surface of the left and right leaflet of the valve which resulted in the leaflets restriction.It was observed upon explant that there was a clot on the valve.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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