Catalog Number UNK CDS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Intracranial Hemorrhage (1891); Perforation (2001); Cardiac Tamponade (2226); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
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Event Date 06/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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(udi#): in the absence of a reported part number, the udi cannot be calculated.The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article attached: minimally invasive mitral valve repair for functional mitral regurgitation in severe heart failure: mitraclip versus minimally invasive surgical approach.
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Event Description
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This is filed to report bleeding, recurrent mitral regurgitation, chordal rupture, cardiac tamponade, stroke, tissue damage and atrial perforation.It was reported through a research article that 24 patients underwent a mitraclip procedure to treat functional mitral regurgitation (mr).Within three years of the mitraclip procedure, it was reported that the implanted clips may have caused or contributed to intracerebral bleeding, recurrent mitral regurgitation (mr), chordal rupture, cardiac tamponade, stroke, tissue damage, atrial perforation, hospitalization and surgical intervention.Details are listed in the attached article, titled ¿minimally invasive mitral valve repair for functional mitral regurgitation in severe heart failure: mitraclip versus minimally invasive surgical approach.¿ no additional information was provided.
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Manufacturer Narrative
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The devices were not returned for analysis.Additionally, a review of the lot history record and complaint history for the reported lot could not be conducted, because the lot number and serial numbers were not provided.All available information was investigated and the reported patient effects of tissue damage, atrial perforation, intracranial hemorrhage, mitral regurgitation, cardiac tamponade and cerebrovascular accident appear to be due to procedural circumstance/operational context.The reported patient effects of tissue damage, atrial perforation, intracranial hemorrhage, mitral regurgitation, cardiac tamponade and cerebrovascular accident as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.Lastly, surgical procedure (due to perforation) and hospitalization are a result of case specific circumstances as documented within the research article.There is no indication of product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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