Model Number 3300TFX |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Endocarditis (1834); Fever (1858); Chills (2191); Confusion/ Disorientation (2553); Insufficient Information (4580)
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Event Date 05/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: additional manufacturer narrative:
surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.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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Event Description
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It was learned through implant patient registry that a 23mm 3300tfx aortic valve was explanted after an implant duration of 4 years, 11 months due to unknown reasons.The explanted valve was replaced with a 23mm 11500a aortic 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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H11: corrected data : based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
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Event Description
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It was learned through implant patient registry and later through medical records that a 23mm 3300tfx aortic valve was explanted after an implant duration of 4 years, 11 months due to endocarditis.The explanted valve was replaced with a 23mm 11500a aortic valve.Per medical records, the patient presented with fever, chills, weakness, gait disturbance and confusion and was diagnosed with septic brain embolic secondary to bacterial endocarditis.Blood cultures showed streptococcus constellatus and was treated with iv antibiotics.The patient underwent redo-avr with a 23mm inspiris valve.Post bypass tee showed normally functioning bioprosthetic av with no pvl.The patient was transferred to icu in stable condition and was discharged on pod#5.
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Search Alerts/Recalls
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