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Catalog Number TFGT-25A |
Device Problems
Incomplete Coaptation (2507); Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2019, a 23mm trifecta gt valve was implanted in a patient.On (b)(6) 2023, the ultrasonic echocardiography showed pannus on the valve.On (b)(6) 2023, the valve got explanted.There was impaired movement of the valve cusp due to pannus, and there was incomplete coaptation was due to separation of cusp.A new 23mm non-abbott valve was chosen and implanted.The patient was reported stable.
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Manufacturer Narrative
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Explant due to an ultrasonic echocardiography showing pannus was reported.The investigation found that leaflets 1 and 2 were torn.There was fibrous pannus ingrowth on the inflow surface of all leaflets and on the outflow of leaflet 1.There was no inflammation or significant calcifications.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.Non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In addition, the pannus noted could have increased stress on adjacent leaflets and created an unbalanced stress relief distribution between all leaflets during coaptation, which may lead to leaflet tears and reduced durability.
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Event Description
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N/a.
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Search Alerts/Recalls
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