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Model Number 11500A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Dyspnea (1816)
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Event Date 02/02/2024 |
Event Type
Injury
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Event Description
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It was learned through implant patient registry that a 25mm 11500a aortic valve was explanted after an implant duration of five (5) years, one (1) month due to thrombosis and regurgitation.The patient presented with dyspnea.The explanted valve was replaced with another 25mm 11500a valve.Per medical records, echocardiogram showed prosthetic aortic valve regurgitation.Intraoperatively, the surgeon noted that the prosthetic aortic valve had multiple tears on the leaflets and thrombus.The valve was excised and the annulus was debrided.A 25mm 11500a was implanted without difficulty.Intraoperative tee showed adequate valve replacement.The patient was transferred to the icu in guarded condition.Per pathology, explanted aortic valve was found to have fibrosis, dystrophic calcification, and adherent thrombotic debris with acute inflammation.Vegetation could not be excluded.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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H11: additional manufacturer narrative: updated sections h6 (component code, type of investigation, investigation findings, investigation conclusions) thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots on the device/graft.There may be cases of incidental finding by imaging (ct scan) of thicken leaflets (halt) when the patient will benefit from a close follow-up and may be treated with oral anticoagulant.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 event in this case was impacted by the progression of the patient's underlying valvular disease pathology with structural valve deterioration and nonstructural dysfunction combined with the patient's other underlying risk factors, including coronary artery disease (cad) and hyperlipidemia (hld).The subject device is not available for evaluation.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.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.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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