Catalog Number UNK CDS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/30/2022 |
Event Type
Death
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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.Date of death estimated.Date of event estimated.The udi number is not known as the part and lot numbers were not provided.Date of implant estimated.Attachment: article titled ¿early outcomes of 2 mitral valve transcatheter leaflet approximation devices".
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Event Description
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This is filed to report a death.It was reported through a research article that 307 patients underwent a mitraclip procedure.During the initial mitraclip procedure and during the 30 day follow up appointment, death was reported.Additional information can be found in the attached article, titled ¿early outcomes of 2 mitral valve transcatheter leaflet approximation devices¿.
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Manufacturer Narrative
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The device was not returned for analysis.The lot history record (lhr) review and complaint history review were not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the reported death could not be determined as no case-specific information was provided.The reported patient effects of death is listed in the mitraclip system instructions for use (ifu) are a known possible complications associated with mitraclip procedures.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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