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Model Number TFGT-A |
Device Problems
Insufficient Information (3190); Material Split, Cut or Torn (4008); Central Regurgitation (4068)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
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Event Description
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It was reported that on an unknown date, a 27mm sjm trifecta gt valve was implanted.On (b)(6) 2022, the valve was explanted due to unknown reasons.The patient status was reported as unknown.
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Event Description
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Subsequent to the initially filed report, the following information was received that: the 27mm trifecta gt valve was implanted on (b)(6) 2017.On an unknown date, aortic regurgitation (ar) was confirmed via echocardiogram during a scheduled follow up exam.Because of the ar, the valve was explanted and the aortic valve replacement was redone with another valve.After the trifecta valve was explanted, a tear was noticed on a leaflet.The patient was reported a recovering without complications.
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Manufacturer Narrative
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Explant due to unknown causes as reported.The investigation found that leaflets 2 and 3 were torn.There was fibrous pannus ingrowth on the inflow and outflow surfaces of leaflet 1 and on the outflow surface of leaflet 3.There was fibrous thickening of all three leaflets.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification at the tear site or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A 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 this case, histological evaluation did not demonstrate loss of collagen at the tear site.The cause of the leaflet tear could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 device code 3190 removed.
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Search Alerts/Recalls
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