Product analysis: no product was returned.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.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.It was reported that this patient's native anatomy made this implant more challenging from a technical perspective.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received information that a cardiac surgery fellow performed an aortic root enlargement on this patient's native aortic valve.Following the root enlargement, the surgeon reported that it was difficult to seat this 21mm bioprosthetic aortic valve.It was reported that the valve appeared to be getting "stuck" on something.The 21mm valve was ultimately implanted with no adverse patient effects reported.Of note, it was reported that this procedure was the surgeon's sixth time using this valve, and the smallest valve of this model that he had implanted previously was a 25mm valve in a patient with annular enlargement.It was reported that this patient's native anatomy made this implant more challenging from a technical perspective.
|