Model Number FR995 |
Device Problems
Gradient Increase (1270); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 11/21/2017 |
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 6 years and 11 months post implant of this bioprosthetic valve, a transcatheter valve was implanted valve-in-valve.The reason for the intervention 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 the transcatheter valve was implanted valve-in-valve due to high gradients of the bioprosthetic valve.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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