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Model Number 19AGN-751 |
Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Dyspnea (1816)
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Event Date 03/07/2019 |
Event Type
Injury
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Event Description
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On (b)(6) 2017, an aortic valve replacement (avr) was performed and a 19mm regent valve was implanted in a female patient.During a follow-up visit on (b)(6) 2019, the patient presented with chest pain and was treated with a thrombolysis course; however, symptoms progressed.The patient underwent a re-do avr procedure and a trifecta gt valve (serial number: unknown) was implanted.The patient is reported to be discharged.
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Event Description
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On (b)(6) 2017, an aortic valve replacement (avr) was performed and a 19mm regent valve was implanted in a female patient.During a follow-up visit on (b)(6) 2019, the patient presented with chest pain and was treated with a thrombolysis course; however, symptoms progressed.The patient underwent a re-do avr procedure and a trifecta gt valve (serial number: (b)(4)) was implanted and the patient has been discharged.Per the physician, pannus was observed on the explanted valve.
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Event Description
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On (b)(6) 2017, an aortic valve replacement (avr) was performed and a 19mm regent valve was implanted in a female patient.During a follow-up visit on (b)(6) 2019, the patient presented with chest pain and was treated with a thrombolysis course; however, symptoms progressed.The patient underwent a re-do avr procedure and a trifecta gt valve (serial number: (b)(4)) was implanted and the patient has been discharged.Per the physician, pannus was observed on the explanted valve.
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Manufacturer Narrative
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Explant was reported due to chest pain and pannus was noted on the explanted valve.Pannus was present on the sewing cuff and extended onto parts of the orifice, but did not impinge upon the leaflets.Both leaflets opened and closed completely and without resistance.No inflammation was present.Surface fungal hyphae were present on the tissue and was interpreted by histopathology to be a contaminant.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.This included sterilization of the device to prevent contamination.The cause of the pannus and fungal hyphae could not be conclusively determined.
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Search Alerts/Recalls
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