Model Number 4100 |
Device Problems
Fluid/Blood Leak (1250); Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
Mitral Regurgitation (1964)
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Event Date 12/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned to edwards for evaluation.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.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.A definitive root cause cannot be determined.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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Edwards received notification that this 32mm ring was explanted after an implant duration of 24 days due to ring dehiscence leading to mitral valve regurgitation.The explanted device was replaced with a non-edwards valve.The outcome was noted as resolved.
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Manufacturer Narrative
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Udi number: (b)(4).The cause of the event remains indeterminable; however, patient factors and progression of underlying valvular disease may have impacted the event.Added codes.Corrected data.Entry error a1.Inadvertently put serial number in lot number field.Added additional device codes that were originally left out.
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Manufacturer Narrative
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Reference capa-20-00141.
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Search Alerts/Recalls
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