Model Number 305U |
Device Problem
Insufficient Information (3190)
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Patient Problems
Aortic Valve Stenosis (1717); High Blood Pressure/ Hypertension (1908); Heart Failure (2206)
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Event Date 04/28/2015 |
Event Type
Injury
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Event Description
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Medtronic received information that one year, five months post implant of this bioprosthetic valve, this valve was explanted and replaced with a 20mm medtronic mechanical aortic heart valve due to stenosis, valve induced class three heart failure, and hypertension.No other adverse patient effects were reported.
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Manufacturer Narrative
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The device has not been returned.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).
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Manufacturer Narrative
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Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.
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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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