Model Number 3300TFX |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
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Event Date 11/07/2023 |
Event Type
Injury
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Event Description
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It was learned through implant patient registry that a patient with a 23mm 3300tfx aortic valve underwent a valve-in-valve procedure after an implant duration of 6 years, 5 months due to unknown reason.The procedure was performed with a 23mm 9755rsl transcatheter valve.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 manufacturer narrative: 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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Manufacturer Narrative
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H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (component code, type of investigation, investigation findings, investigation conclusions).Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.The root cause of this event cannot be conclusively determined with the available information.However, patient and/or procedural factors likely caused or contributed.The subject device is not available for evaluation as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues 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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Event Description
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It was learned through implant patient registry and investigation that a patient with a 23mm 3300tfx aortic valve underwent a valve-in-valve procedure after an implant duration of 6 years, 5 months due to patient prothesis mismatch.The patient presented with symptoms of heart failure.The tavr procedure was performed with a 23mm 9755rsl valve.The patient was discharged on pod #1.
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Manufacturer Narrative
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H10: additional manufacturer narrative: updated sections b5, b7, d4 (udi number), h6 (health effect - clinical code, device code).
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Search Alerts/Recalls
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