Catalog Number CDS0702-XTW |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2024 |
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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported incomplete coaptation (slda, single leaflet device attachment), associated with the clip detachment from posterior leaflet after deployment, was due to pre-existing patient anatomy with indentation on posterior leaflet as per the physician.The reported image resolution poor was due to a combination of challenging patient anatomy and shadowing from the device.The reported unexpected 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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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, bi-leaflet prolapse, and an enlarged atrium.It was noted imaging was challenging throughout the procedure.An xtw 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, two additional clips were implanted, reducing mr to a grade of 3.There was no clinically significant delay in the procedure.
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Search Alerts/Recalls
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