The patient had a myocardial infarct on (b)(6) 2015 and experienced a post infarct ventricular septal defect (pivsd) which was surgically repaired with a bovine pericardial patch.On (b)(6) 2015, the patient was admitted with congestive heart failure (chf) secondary to two separate shunts around the dehisced vsd patch.Treatment included diuretics and inotropes.An emergent pivsd repair was performed on (b)(6) 2015.During the procedure, the primary and larger residual vsd was measured on echo (ice) at approximately 8 mm in diameter on the right ventricle side and 9 mm in diameter on the left ventricle side.The septal thickness was approximately 8 mm.An 18mm amplatzer muscular vsd occluder (muscvsd) was successfully implanted.The following morning on (b)(6) 2015, the patient's chf symptoms worsened and a tte was performed, which documented the muscvsd appeared to have shifted.Hemolysis was confirmed by laboratory findings.The patient was placed on an iabp and treated for low hemocrit and hemoglobin.The patient is not a surgical candidate.
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(b)(4).The results of this investigation are inconclusive because the amplatzer muscular vsd occluder was not returned for evaluation.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder and the cause for the reported event remains unknown.
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