(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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On (b)(6) 2015, a mitral valve replacement procedure was performed due to mitral stenosis in a patient with a heavily calcified annulus.The annulus was sized with a sjm 905 sizer set and measured between 21 mm and 23 mm.This 23 mm sjm masters series mechanical heart valve was selected and seated in the annulus without difficulty.Intraoperatively when coming off cardiopulmonary bypass, a rupture of the left ventricle (class1, blow-out type) occurred which required repair and the 23mm valve was removed.A smaller 21 mm sjm masters series mechanical heart valve was implanted.The procedure time was prolonged, but was completed successfully and the patient was reported to be stable postoperatively.According to the physician, the rupture of the left ventricle was caused by over-sizing as the 23 mm valve was too tight for the patient's annulus.
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