Catalog Number CDS0702-XTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Calcium Deposits/Calcification (1758); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/06/2022 |
Event Type
Death
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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 this event.Based on available information, the cause of the reported death/expired could not be determined.The reported patient effect of death, 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 report is being filed due to a patient death, unknown if device related.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with functional mitral regurgitation (mr) grade 4+, with mitral annular calcification and leaflet tethering.One mitraclip was implanted, reducing the mr to grade 1+ and 3+.There was no device deficiency.On (b)(6) 2022, the patient expired.The cause of death was unknown.
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Search Alerts/Recalls
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