Catalog Number CDS0706-XTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 03/19/2024 |
Event Type
Injury
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Manufacturer Narrative
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The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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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.An xtw clip was inserted; however, before deployment, thrombosis was noted in the left atrium (la).To treat the thrombosis, heparin was administered to the patient.The procedure was continued, and the clip was successfully deployed, 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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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.Based on available information, the cause of the reported thrombosis was unable to be determined.The reported patient effect of thrombosis/thrombus, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported medication required 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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