(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 angina, myocardial infraction and thrombosis 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.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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 underwent a coronary procedure with implantation of a 3.5 x 18 mm absorb bioresorbable vascular scaffold (bvs) in the distal right coronary artery.On (b)(6) 2014, the patient was re-hospitalized with chest pain, diagnosed as acute inferior myocardial infarction.Cardiac enzymes were elevated.Medications were administered.Coronary angiography was performed on (b)(6) 2014 and noted scaffold thrombosis.Aspiration was performed, using an aspiration catheter.Angioplasty was performed, with implantation of a stent.The patient condition resolved on (b)(6) 2014.No additional information was provided.
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