Catalog Number CDS0702-NTW |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
Injury
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Event Description
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It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4 with thin and calcified leaflets.An ntw clip was inserted and deployed on the mitral valve.However, after deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda and further reduce mr, an additional clip was implanted, reducing mr to a grade of 1+.There was no clinically significant delay in the procedure.
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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 quality issue.Based on available information, the cause of the reported incomplete coaptation is due to patient anatomy (a thin and fragile leaflet).The reported 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.
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Search Alerts/Recalls
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