Model Number FR995-25 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Endocarditis (1834); Pseudoaneurysm (2605)
|
Event Date 12/11/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Product analysis: no product was returned.Conclusion: 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.
|
|
Event Description
|
Medtronic received information that 1 month 20 days post implant of this 25mm aortic bioprosthetic valve, the patient was admitted for endocarditis.Computed tomography (ct) evaluation showed a mycotic pseudoaneurysm.Initially the patient was treated with antibiotics, which did not resolve the infection and the valve was explanted and replaced (replacement product not specified) approximately 4 months post implant.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Medtronic received additional information that the endocarditis was from streptococcus mitis.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|