Catalog Number UNK SGC03 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Perforation (2511)
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Event Date 11/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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Dates estimated.(udi#): in the absence of a reported part number, the udi number cannot be calculated.The device is not returning.Investigation is not yet completed.A follow-up report will be submitted with all additional relevant information.
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Event Description
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This is filed to report the atrial perforation requiring intervention.It was reported through a research article identifying the mitraclip device used in a (b)(6)year old female which experienced atrial perforation, bidirectional shunt immediately after the procedure.An occluder was used for treatment.Details are listed in the article, management of iatrogenic atrial septal defects in the era of large bore transcatheter mitral valve therapies.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record could not be performed as lot and part numbers were not provided.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use and is a known possible complication of mitraclip procedures.The additional therapy/non-surgical treatment is the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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