Model Number FR995 |
Device Problems
Material Perforation (2205); Insufficient Information (3190)
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Patient Problems
Aortic Insufficiency (1715); Tissue Damage (2104); No Information (3190)
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Event Date 05/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 3 years and 10 months post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with a valve of the same size and model. the reason for the explant was not reported. no additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information that this valve was explanted due to severe insufficiency.Upon removal the physician reported there was a large perforation and tissue damage to both the right and non-coronary cusps.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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