Catalog Number UNK CDS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Stroke/CVA (1770); Thrombosis (2100); Heart Failure (2206)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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The udi is unknown because the part number and lot number were not provided.The devices were not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported patient effects of cerebrovascular accident, heart failure, atrial fibrillation, and thrombosis could not be determined.The reported patient effects of cerebrovascular accident, heart failure, atrial fibrillation, and thrombosis as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature article title ¿prevalence of in-hospital stroke comparing mitraclip and transcatheter aortic valve implantation¿.
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Event Description
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This is filed to report stroke, thrombosis, heart failure, atrial fibrilliation, and prolonged hospitalization.It was reported through a research article identifying mitraclip devices that were related to the following outcomes: stroke, thrombosis, heart failure, atrial fibrilization, and prolonged hospitalization.Specific patient information is documented as unknown.Details are listed in the article, titled "prevalence of in-hospital stroke comparing mitraclip and transcatheter aortic valve implantation." no additional information was provided.
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Search Alerts/Recalls
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