Model Number 305C |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problems
Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)
|
Event Date 11/15/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
The device remains implanted and will not be returned for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.
|
|
Event Description
|
Medtronic received information that four years and four months post implant of this bioprosthetic valve, it was replaced valve-in-valve due to stenosis and regurgitation with 2/3 systemic right ventricle pressures.No other adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|