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Catalog Number SGC0705 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Date 01/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 the reported event.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported patient effect of atrial perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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This is filed to report atrial perforation it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The mitraclip was successfully implanted, reducing mr to a grade of 2.However, after the steerable guide catheter (sgc) was removed, a right to left shunt was observed; therefore, the physician decided to treat it with an amplatzer closure device.There was no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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