Model Number 7300TFX |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Malaise (2359); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Date 01/31/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient with a 33mm mitral valve is being evaluated for a valve-in-valve procedure after an implant duration of 6 years, 1 month due to unknown reasons.
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Manufacturer Narrative
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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 device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that a patient with a 7300tfx 33mm mitral valve is being evaluated for a valve-in-valve procedure after an implant duration of 6 years, 1 month due to thrombosis and stenosis.The patient presented with sob, worsening doe, and malaise.
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Manufacturer Narrative
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H10: additional narratives.Updated b5, b7, and h6 per new information received.
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Manufacturer Narrative
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H11: additional narratives: updated d4, h4, and h6 per new information received.The most likely cause is patient factors.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all 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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