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Model Number 11500A |
Device Problems
Calcified (1077); Gradient Increase (1270); Patient-Device Incompatibility (2682)
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Patient Problem
Dyspnea (1816)
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Event Date 08/31/2023 |
Event Type
Injury
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Event Description
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It was learned through implant patient registry and investigation that a 21mm 11500a aortic valve was explanted after an implant duration of 3 years, 8 months due to moderate calcification, severe stenosis, and possible patient prosthesis mismatch.The explanted valve was replaced with a 25mm 11500a valve.Per medical records, the patient presented very short of breath and underwent redo avr and mitral valve repair with 30mm physio i ring.Intraoperatively, aortic valve was moderately calcified and excised.A 25mm 11500a valve was implanted and secured with cor-knots.Post procedure tee showed no mitral regurgitation and the patient transferred in stable condition to the icu.Cardiology outpatient f/u on pod #20, showed patient is doing very well, echo results were not provided, patient is on aspirin 81mg twice a day and warfarin qd.The device was discarded, and pathology was not performed.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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Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.The root cause of this event was determined to be due to patient related factors.The calcification observed in this case was due to a progression of the patient's underlying valvular disease pathology combined with the patient's other underlying risk factors, including end stage renal disease (esrd) with hemodialysis and hyperlipidemia (hld).The subject device is not available for evaluation as it was discarded.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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Search Alerts/Recalls
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