ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number TF-23A |
Device Problem
Torn Material (3024)
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Patient Problem
Aortic Insufficiency (1715)
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Event Date 06/08/2017 |
Event Type
Injury
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Event Description
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On (b)(6) 2012, a (b)(6) male with a past medical history of hypertension underwent an aortic valve replacement (avr) for a congenital biscupid valve and this 23 mm trifecta valve was implanted.On (b)(6) 2017, the patient presented to the emergency room and re-do avr was performed.Upon explant, a leaflet tear was observed along the stent post between the left coronary cusp (lcc) and the non-coronary cusp (ncc) toward the lcc side.A 23 mm medtronic mosaic tissue valve was implanted.The patient has been in stable condition postoperatively.
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Manufacturer Narrative
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The results of this investigation concluded leaflets 1 and 3 were torn.There was circumferential fibrous pannus ingrowth on the inflow surface which resulted in the narrowing of the inflow diameter.There was focal thrombus on the outflow surface of leaflet 2.No acute inflammation or significant calcifications were present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the tears, pannus, or thrombus were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.
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