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 02/28/2024 |
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.The investigation determined the reported slda appears to be related to patient morphology/pathology.There is no indication of a product issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), restricted anterior and posterior mitral leaflet for a mitraclip procedure.It was noted that there were no issues with leaflet insertion.The second clip was deployed and a single leaflet device attachment (slda) occurred 30 seconds after release.The clip detached from the anterior leaflet.The mr was reduced to grade 1.No additional treatment was required, as the slda clip appeared to act as a plug during 1/2 of the cardiac cycle and decreased mr.There were no adverse patient effects or clinically significant delay.
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Search Alerts/Recalls
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