Catalog Number SGC0302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994)
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Event Date 12/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of hematoma, hemorrhage and pain as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported hematoma, hemorrhage and pain appear to be related to patient morphology/pathology and/or user technique/procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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This is filed for hematoma requiring surgical intervention.It was reported that on (b)(6) 2018, the patient underwent a mitraclip procedure, treating grade 3+ functional mitral regurgitation (mr).One clip was implanted, reducing mr to grade 1+.On (b)(6) 2018, the patient experienced a painful hematoma at the access site, with bleeding and remained hospitalized.On (b)(6) 2018, surgical removal of the hematoma was performed.The event resolved on (b)(6) 2019.No additional information was provided.
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Search Alerts/Recalls
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