Model Number 3300TFX |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
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Event Date 12/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned to edwards for evaluation as it was discarded.Attempts to retrieve additional information is in process.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 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 a 3300tfx 21mm bioprosthetic aortic valve, implanted for three (3) years, was explanted due to unknown reasons.The explanted device was replaced with an 8300ab 23mm intuity elite valve.Post operative status noted as in recovery.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 and investigation that a 3300tfx 21mm bioprosthetic aortic valve, implanted for three (3) years, was explanted due to perivalvular leak (pvl).Patient presented with heart failure.The explanted device was replaced with an 8300ab 23mm valve.Post op patient's status noted in recovery.
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Manufacturer Narrative
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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.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.The most likely cause is patient factors, including hyperlipidemia (hld).
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Search Alerts/Recalls
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