Catalog Number SGC0702 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
|
Event Date 02/08/2022 |
Event Type
Injury
|
Event Description
|
This is filed to report thrombus and tissue damage.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.Two clips were deployed on the mitral valve, reducing mr to a grade of <1.The steerable guide catheter (sgc) was retracted from the left atrium to the right atrium, but a fluttering object was observed at the septum.It was unknown if the object was thrombus or tissue.Aspiration was performed and the object was successfully removed.There was no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported thrombus and unspecified tissue injury could not be determined.Thrombosis/thrombus and tissue injury are listed in the mitraclip system instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|