Catalog Number CDS0706-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 03/06/2024 |
Event Type
Injury
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Event Description
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It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ and a pre-existing big stitch located on the a2 leaflet.A mitraclip xtw 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 clip, an additional clip was implanted, reducing the mr from torrential to grade 2+.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 slda and difficult imaging were unable to be determined.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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Search Alerts/Recalls
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