Catalog Number UNK CDS |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Renal Failure (2041); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 05/01/2014 |
Event Type
Injury
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Event Description
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This is filed to report worsening mitral regurgitation (mr), severe mitral stenosis, mitral valve replacement, gastrointestinal bleeding, sepsis, renal failure, postoperative atrial fibrillation, stroke, and prolonged hospitalization due to heart failure.This research article was a retrospective study designed to highlight the potential of surgery as an option for high-risk patients who underwent transcatheter edge-to-edge repair and developed recurrent mitral regurgitation.Complications identified in the study included: single leaflet device attachment, difficult to remove, worsening mr, severe mitral stenosis, mitral valve replacement, gastrointestinal bleeding, sepsis, renal failure, postoperative atrial fibrillation, stroke, prolonged hospitalization due to heart failure, death.In conclusion surgical treatment of severe mr after mitral teer is feasible but requires mitral valve replacement.Compared with medical therapy, mitral surgery is associated with significantly lower risk-adjusted all-cause mortality during midterm follow-up.
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Manufacturer Narrative
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The devices will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event, implant date/explant date: dates estimated.The udi number is not known as the part and lot number were not provided.The additional malfunctions and death reported in the article are captured under a separate medwatch report number.Article titled, "mitral valve surgery for persistent or recurrent mitral regurgitation after transcatheter edge-to-edge repair is associated with improved survival"na.
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Manufacturer Narrative
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The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was 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 valve insufficiency/ regurgitation (worsening mr), mitral stenosis, hemorrhage (blood transfusion), sepsis, renal failure, atrial fibrillation, cerebrovascular accident, unrelated death, and heart failure/congestive heart failure (prolonged hospitalization) could not be determined.The cause of the reported incomplete coaptation could not be determined.The reported patient effects of mitral regurgitation, atrial fibrillation, sepsis, mitral stenosis, hemorrhage, renal failure, cerebrovascular accident, death, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention, hospitalization, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided.The additional malfunctions and death reported in the article are captured under a separate medwatch report number.
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Search Alerts/Recalls
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