Model Number FR995 |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problems
Aortic Valve Stenosis (1717); No Information (3190)
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Event Date 11/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: the device remains implanted, therefore 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 5 years 9 months post implant of this aortic bioprosthetic valve, the patient was being considered for a valve-in-valve replacement procedure for unknown reasons.Subsequently 7 days later an attempted valve-in-valve procedure was performed which was unsuccessful.The physician was unable to successfully pass a new device across the aortic valve and chose to abandon the case.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that the reason for the attempted replacement was aortic stenosis.No additional adverse patient effects were reported. a review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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