Catalog Number UNK CDS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Renal Failure (2041); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
|
Event Date 10/30/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Implant date: date of implanted estimated.Attachment: article titled ¿early outcomes of 2 mitral valve transcatheter leaflet approximation devices".
|
|
Event Description
|
This is filed to report bleeding, tissue damage, stroke, mitral stenosis, recurrent mitral regurgitation and renal failure.It was reported through a research article that 307 patients underwent a mitraclip procedure.During the initial mitraclip procedure and during the 30 day follow up appointment, the following was reported: bleeding, structural damage, mitral valve replacement, prolonged hospitalization, medical intervention, stroke, mitral stenosis, recurrent mitral regurgitation (mr), and renal failure requiring dialysis.Additional information can be found in the attached article, titled ¿early outcomes of 2 mitral valve transcatheter leaflet approximation devices.¿.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.The lot history record (lhr) review and complaint history review were not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the reported mitral stenosis, tissue injury (structural damage), hemorrhage (bleeding), cerebrovascular accident (stroke), renal failure and recurrent mr could not be determined as no case-specific information was provided.The reported patient effects of mitral stenosis, tissue injury, hemorrhage, cerebrovascular accident, renal failure, and mitral regurgitation, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported medication required, unexpected medical intervention, surgical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|
|