Catalog Number CDS0702-XTW |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 01/19/2024 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat functional (mr) with a grade of 3.One clip was implanted, reducing mr to a grade of 1.On (b)(6) 2024, the patient returned to the hospital for a follow-up appointment and imaging showed the implanted clip had detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 3.On (b)(6) 2024 an additional mitraclip was performed, and one clip was implanted, reducing mr to a grade of 1.
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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.Additionally, a review of the complaint history did not indicate a lot specific issue.Based on available information, the cause of the reported incomplete coaptation cannot be determined.The reported mr appears to be a cascading effect of the reported incomplete coaptation.Additionally, the reported patient effect of mitral regurgitation is listed in the instructions for use, and is a known possible complication associated with mitraclip procedures.The reported medical intervention and hospitalization were results of case-specific circumstances.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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