ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL
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Model Number 19AGFN-756 |
Device Problem
Obstruction of Flow (2423)
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Patient Problems
Thrombus (2101); Heart Failure (2206); Stenosis (2263)
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Event Type
Injury
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Manufacturer Narrative
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Further information regarding this event has been requested.
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Event Description
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On (b)(6) 2007, a 19mm regent valve was implanted in the aortic position.In (b)(6) 2018, high gradient and stenosis were observed and on (b)(6) 2018, the patient was admitted to the hospital for heart failure.On (b)(6) 2018, a valve replacement surgery was performed and the valve was exchanged for another 19mm regent valve (serial number: (b)(4)).The physician reports thrombotic material on the explanted valve that was reported to have obstructed leaflet function.Of note, the patient has another mechanical mitral valve with no thrombotic issues and will continue to be monitored for any non-diagnosed thrombophilia problems.The physician suggests that coagulation alterations in combination with the small size of the valve caused the thrombotic material formation.The patient is reported to be discharged.
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Event Description
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On (b)(6) 2007, a 19mm regent valve was implanted in the aortic position.In (b)(6) 2018, high gradient and stenosis were observed and on (b)(6) 2018, the patient was admitted to the hospital for heart failure.On (b)(6) 2018, a valve replacement surgery was performed and the valve was exchanged for another 19mm regent valve (serial number: (b)(6)).The physician reports thrombotic material on the explanted valve that was reported to have obstructed leaflet function.Of note, the patient has another mechanical mitral valve (serial number: (b)(6)) with no thrombotic issues and will continue to be monitored for any non-diagnosed thrombophilia problems.The physician suggests that coagulation alterations in combination with the small size of the valve caused the thrombotic material formation.The patient is reported to be discharged.
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Manufacturer Narrative
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Explant was reported due to high gradient, stenosis, and heart failure.The thrombotic material seen at explant was confirmed.There was thrombotic material in the pivot recesses, which limited the mobility of the leaflets.No acute inflammation was present.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.The cause of the thrombosis could not be conclusively determined; however, per the site the physician suggested that "coagulation alterations in combination with the small size of the valve caused the thrombotic material formation.".
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