Catalog Number CDS0706-XTW |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
Injury
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Event Description
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It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+ and a pre existing chordal rupture.An xtw clip was inserted and was advance under the valve.However, the clip became caught in the chordae and was unable to be removed.It was observed that a chordal rupture occurred.Although the clip remained in the chordae, it was able to grasp both leaflets.An additional clip was implanted to stabilize the first clip, 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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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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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 cause of the reported clip caught in chordae was unable to be determined.The reported unexpected medical intervention and unexpected medical intervention were results 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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