EDWARDS LIFESCIENCES SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number 9755RSL23A |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is still ongoing.
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Event Description
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As reported by an edwards canada affiliate, during a transfemoral tavr procedure with a 23mm sapien 3 ultra resilia transcatheter heart valve, about 8 minutes after successful deployment, tte was done, and tissue was observed that appeared dense and was moving at the base of the valve.That tissue could not be seen on fluoro.The patient was not known to have hyperthermia before the procedure.It is unclear what was it, however, it was thought to possibly be calcification in the left ventricular outflow tract that became mobile or a damaged skirt of the prosthesis valve.The patient was not experiencing any symptoms or deterioration, and no actions were taken and/or planned to be performed.The patient was discharged home and was fine.
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Manufacturer Narrative
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Correction based on additional information.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, the complaint for valve damaged was unable to be confirmed due to unavailability of the device, medical records, and/or applicable imagery.A review of the device history record and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.As no procedural imagery was provided and due to limited information provided a definitive root cause was unable to be determined.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.
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