Model Number 7300TFX |
Device Problems
Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Dizziness (2194); Insufficient Information (4580)
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Event Date 10/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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The subject device is not available for evaluation, as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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It was learned via the implant patient registry that this patient with a 7300tfx 27mm mitral valve, implanted for seven (7) years and six (6) months, underwent a valve-in-valve procedure due to unknown reasons.The tmvr was performed with a 9750tfx 26mm.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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Event Description
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It was learned via the implant patient registry that this patient with a 7300tfx 27mm mitral valve, implanted for seven (7) years and six (6) months, underwent a valve-in-valve procedure due to pvl secondary to valve dehiscence.The patient presented with shortness of breath and dizziness.The tmvr was performed with a 9750tfx 26mm.The patient outcome at the end of the procedure as stable.
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Manufacturer Narrative
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Updated sections: d4 expiration date, g3, g6, h4, h6 type of investigation, investigation findings, investigation conclusions.The device history record 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.Device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device 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.Valve dehiscence is not a malfunction of the device.Through further investigation, it was determined that a definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.
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Search Alerts/Recalls
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