Model Number 5200 |
Device Problems
Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)
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Patient Problems
Mitral Regurgitation (1964); Organ Dehiscence (2502)
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Event Date 04/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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Udi (b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.A manufacturing related issue was not identified.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.
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Event Description
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It was reported that a 28mm ring was explanted after six months due to dehiscence and severe eccentric mitral regurgitation.A 30mm ring was implanted in replacement.The mitral valve was interrogated showing no residual mitral regurgitation.The patient also received a 32mm 5200 ring in tricuspid position.The tricuspid valve was interrogated showing no residual tricuspid regurgitation.The patient tolerated the procedure well and was transferred to the icu in stable condition.The patient was discharged on pod #7 in good condition.There is no allegation of ring malfunction.
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Manufacturer Narrative
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H11.Corrected data- updated section h6 (conclusion).
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-0014.
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Search Alerts/Recalls
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