Catalog Number SGC0302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Perforation (2511)
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Event Date 12/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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This is filed to report the atrial septal defect (asd) it was reported that this was a mitraclip procedure performed to treat grade 3-4 functional mitral regurgitation (mr).One clip was implanted, successfully reducing mr to 1.After the mitraclip procedure, an atrial septal defect (asd) was observed and an occluder was implanted to close the asd.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of atrial septal defect (cardiac perforation) is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.The reported atrial perforation appears to be related to patient morphology/pathology and/or user technique/procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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