ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL
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Model Number 21AGFN-756 |
Device Problems
Gradient Increase (1270); Patient Device Interaction Problem (4001)
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Patient Problems
Aortic Regurgitation (1716); Dyspnea (1816); Thrombus (2101); Stenosis (2263)
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Event Date 03/30/2019 |
Event Type
Injury
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Event Description
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On (b)(6) 2014, a 21mm regent valve was implanted.In (b)(6) 2019, the patient presented to the hospital with dyspnea.A tee was performed revealing stenosis of the valve.The patient was discharged but was admitted again two months later with the same complaint.The physician reported that the patient had psychiatric issues and that the patient didn't adhere properly to the anticoagulation therapy.On (b)(6) 2019, the valve was explanted and replaced with a 21mm magna ease tissue valve so that the patient wouldn't require anticoagulation therapy.
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Manufacturer Narrative
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The reported event of stenosis was confirmed.There was pannus ingrowth on the inflow surface, which narrowed the inflow diameter.Thrombus was found in the pivot areas, and was gram stained for bacteria, which was negative.The leaflets had limited mobility due to the pannus and the thrombi in the pivot recesses.Microcalcifications were present within the pivot thrombi and pannus.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 pannus and thrombus could not be conclusively determined, however, information form the field indicated "the patient had psychiatric issues and that the patient didn't adhere properly to the anticoagulation therapy".
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Event Description
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On (b)(6) 2014, a 21mm regent valve was implanted.In (b)(6) 2019, the patient presented to the hospital with dyspnea.A tee was performed revealing stenosis of the valve.The patient was discharged but was admitted again two months later with the same complaint.The echocardiogram revealed 3rd degree aortic insufficiency and high gradients.The physician reported that the patient had psychiatric issues and that the patient didn't adhere properly to the anticoagulation therapy.On (b)(6) 2019, the valve was explanted and replaced with a 21mm magna ease tissue valve so that the patient wouldn't require anticoagulation therapy.
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Search Alerts/Recalls
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