|
Model Number 505DA22 |
Device Problem
Incomplete Coaptation (2507)
|
Patient Problems
Endocarditis (1834); Occlusion (1984)
|
Event Type
Injury
|
Manufacturer Narrative
|
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 an unknown duration post implant of this aortic mechanical valve, the patient developed endocarditis and underwent bentall operation.Then, an unknown duration post procedure, the patient underwent operation again due to occlusion of the coronary ostium.At that time, leaflet motion blocked for unknown reasons.The surgeon rotated the valve and then the leaflet issue was resolved.No additional adverse patient effects were reported. .
|
|
Manufacturer Narrative
|
Medtronic received additional information that this mechanical valve was implanted during the bentall operation.Therefore, the endocarditis infection occurred prior to implant of this mechanical valve and is not related to the device.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|