Model Number 305 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Aortic Valve Stenosis (1717); Congestive Heart Failure (1783); No Information (3190)
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Event Date 06/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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The available information indicates the device remains implanted.Additional information has been requested regarding the device's functionality, any adverse patient effects and the patient's weight.A supplemental report will be filed if additional information is received and/or when investigation is completed.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 thirteen years, four months post-implant of this bioprosthetic aortic valve, this device was rep laced valve-in-valve with a transcatheter bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the patient had symptoms of congestive heart failure (chf) due to stenosis of the valve.Patient weight entered.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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