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); Insufficient Information (4580)
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Event Date 02/23/2024 |
Event Type
Injury
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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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Event Description
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It was learned through implant patient registry that a patient with a 27mm 3300tfx aortic valve was explanted after an implant duration of 6 years, 4 months due to unknown reason.The explanted valve was replaced with a 27mm 11500a valve.The patient was in recovery post procedure.The patient concomitantly underwent mvr with a 31mm 11400m valve.
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Manufacturer Narrative
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Intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patient's body and is not in any way related to the sterilization or packaging process of the device.Corrected data: based on the additional information, 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 investigation that a patient with a 27mm 3300tfx aortic valve was explanted after an implant duration of 6 years, 4 months due to acute mssa endocarditis.The explanted valve was replaced with a 27mm 11500a valve.Concomitant mvr was performed with a 31mm 11400m valve.The patient was in recovery post procedure.
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Search Alerts/Recalls
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