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 01/16/2024 |
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 did not indicate a lot-specific quality issue.Based on available information, the cause of the reported incomplete coaptation is due to patient anatomy.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.Na.
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Event Description
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.An xtw clip was inserted and deployed on the mitral valve.However, after deployment, the clip detached from 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 2+.There was no clinically significant delay in the procedure.
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Search Alerts/Recalls
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