Model Number 800SR28 |
Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Mitral Regurgitation (1964); No Known Impact Or Consequence To Patient (2692); No Information (3190)
|
Event Date 06/05/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
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 immediately after implanting this 28mm annuloplasty ring in the mitral position, the ring was explanted and replaced with a 31mm bioprosthetic valve.The physician indicated the valve could not be repaired and had to be replaced.No additional adverse patient effects were reported. .
|
|
Manufacturer Narrative
|
Medtronic received additional information that the repair was not sufficient due to severe residual regurgitation, caused by the severity of the patient's valvular disease.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|