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Model Number 11500A |
Device Problems
Calcified (1077); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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It was learned via the implant patient registry that an 11500a 23mm inspiris resilia aortic valve, implanted for one (1) year and two (2) months, was explanted due to unknown reasons.The explanted device was replaced with an 11500a 21mm inspiris resilia 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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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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Event Description
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It was learned via the implant patient registry that an 11500a 23mm inspiris resilia aortic valve, implanted for one (1) year and two (2) months, was explanted due to calcification.The explanted device was replaced with an 11500a 21mm inspiris resilia valve.
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Manufacturer Narrative
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The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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 valves 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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.
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Search Alerts/Recalls
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