Catalog Number UNK CDS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tricuspid Regurgitation (2112); Pericardial Effusion (3271)
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Event Date 01/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date is estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date: date is estimated.The clips remain in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other patient events listed in the article are filed under separate medwatch report numbers.Attached literature title : tricuspid regurgitation after transcatheter mitral valve repair: clinical course and impact on outcome.
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Event Description
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This is filed to report the serious injuries.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, recurrent tricuspid regurgitation, pericardial effusion, and medical intervention.Device issues include, single leaflet device attachment (slda).Details are listed in the attached article, titled "tricuspid regurgitation after transcatheter mitral valve repair: clinical course and impact on outcome.".
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Manufacturer Narrative
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The devices were not returned for analysis.A review of the lot history records could not be performed due to unknown lot information.Additionally, a review of the complaint histories could not be performed due to unknown lot information.The reported patient effects of recurrent tricuspid regurgitation, and pericardial effusion are listed in instructions for use, as known possible complications associated with mitraclip procedures.A cause for the recurrent tricuspid regurgitation and pericardial effusion could not be determined.The additional therapy/non-surgical treatment was a 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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