Model Number 11500A |
Device Problems
Perivalvular Leak (1457); Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/16/2021 |
Event Type
Injury
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Event Description
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It was learned from implant patient registry that a 29mm aortic valve was explanted and replaced with an inverted 33mm valve after an implant duration of 6 months due to severe perivalvular leak and dehiscence.Per medical records, the pre-op echo demonstrated rocking motion of the valve concerning dehiscence of the anterior aspect of the valve.A repair of aortomitral discontinuity using bovine pericardial patch was performed concurrently.The patient was discharged home in stable condition on pod #6.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.
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Manufacturer Narrative
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Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation 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.The device was not returned for evaluation, as it was discarded.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Manufacturer Narrative
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Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation 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.The device was not returned for evaluation, as it was discarded.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was learned from implant patient registry that a 29mm aortic valve was explanted and replaced with an inverted 33mm valve after an implant duration of 6 months due to severe perivalvular leak and dehiscence.Per medical records, the pre-op echo demonstrated rocking motion of the valve concerning dehiscence of the anterior aspect of the valve.A repair of aortomitral discontinuity using bovine pericardial patch was performed concurrently.The patient was discharged home in stable condition on pod #6.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.
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Manufacturer Narrative
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H10: additional narrative: the root cause of this event cannot be conclusively determined.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.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.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Search Alerts/Recalls
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