EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Endocarditis (1834); Insufficient Information (4580)
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Event Date 11/02/2022 |
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 11500a aortic valve implanted for 2 years 10 months was explanted due to unknown reasons.A 23mm 11500a valve was implanted in replacement.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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Manufacturer narrative: updated sections: b5, b7, d4 udi number, g3, g6, h6 health effect - clinical code, device code(s), and investigation findings.Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset at 60 days or less postimplant) and late (onset greater than 60 days post-implant).Early-onset generally reflects contamination arising in the perioperative period; if there were ever non-conformances in the sterility or packaging processes, they would most likely manifest at this time.Late-onset occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not related to the sterilization or packaging process.In this case the onset was greater than 60 days post-implant.H11corrected data: based on the new information received, this event is no longer considered reportable.
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Event Description
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It was learned through implant patient registry that a patient with a 23mm 11500a aortic valve implanted for 2 years 10 months was explanted due to endocarditis with root abscess.A 23mm 11500a valve was implanted in replacement.Per additional information, the patient presented with general malaise, weakness, weight loss, and a recent fall.
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