(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is not returning.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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It was reported that on (b)(6) 2014, the patient presented with an acute st-elevated myocardial infarction (stemi).A 2.5 x 18 mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the distal right coronary artery (rca) lesion.On (b)(6) 2016, the patient was hospitalized for chest pain.Elevated troponin was noted and a new stemi was diagnosed.Per imaging, the proximal lad was 70% stenosed as previously seen in 2014.The rca was subtotally occluded with thrombus at the proximal end of the previously implanted bvs location.A 2.5 x 12 mm xience stent was implanted in the posterior descending and posterior left ventricular branch of the rca.There was no additional information provided regarding this issue.
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(b)(4).The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effects of angina, myocardial infarction and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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