(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The reported patient effects of perforation and death, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events 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 there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that on (b)(6) 2015, the patient underwent a coronary procedure, with successful implantation of a 3.0 x 28 mm absorb bioresorbable vascular scaffold (bvs) in the mid left anterior descending artery.A perforation was noted in the diagonal branch and a second, non-abbott stent was implanted in the same target lesion.At the one year follow up date, the patients family reported that the patient had died.No additional information was provided.
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