EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number 9300TFX26A |
Device Problems
Degraded (1153); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/27/2023 |
Event Type
Injury
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Event Description
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As reported by the field clinical specialist, approximately 7 years, 9 months, post-implant of a 26 mm sapien xt valve in the aortic position, the valve requires intervention and valve in valve will be performed.Although no medical records have been received to date, the reason for intervention provided was aortic valve ''failure with severe aortic regurgitation''.
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Manufacturer Narrative
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Investigation is ongoing.
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Manufacturer Narrative
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A supplemental mdr is being submitted for additional information from medical records.The following sections of this report has been updated: update to b4, b5, b7, g3, g6, h2, h10.
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Event Description
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As reported by the field clinical specialist, approximately 7 years, 9 months, post-implant of a 26 mm sapien xt valve in the aortic position, the valve requires intervention and valve in valve will be performed.The reason for viv is bioprosthetic aortic valve failure with severe regurgitation.
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Manufacturer Narrative
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A supplemental mdr is being submitted for additional information from medical records.The following sections of this report has been updated: update to b4, g3, g6, h2, h10.Per the instructions for use (ifu), structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis), and device degeneration are known potential risks associated with bioprosthetic heart valves.The ifu cautions that accelerated deterioration of the valve may occur in patients with an altered calcium metabolism.Long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd may be mild and not require any intervention or it may be moderate to severe.It can cause the heart to work harder to eject blood from the ventricle.Depending on the severity it could be an indication for valve replacement or medical intervention.Tissue calcification is a very common failure mode.The mechanisms for bioprosthetic heart valve tissue calcification are not yet fully understood.Many factors can contribute to the onset and propagation of calcification including patient-related (e.G., patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.During the manufacturing process, all sapien thv valves are 100% visually inspected for defects and 100% functionally tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive as the exact causes of the degeneration are unknown, however it may be related to the patient's disease state and comorbidities.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.
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