(b)(4).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, arrhythmia and stenosis are listed in the absorb bioresorbable vascular scaffold (bvs) system, absorb, instructions for use instructions for use (ifu) as 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.
|
It was reported that on (b)(6) 2013, the patient underwent a coronary procedure with implantation of a 3.0 x 18 mm absorb bioresorbable vascular scaffold (bvs) in the mid left anterior descending (lad) artery.In (b)(6) 2017, the patient reported having chest pain and palpitations, and was having anxiety.Medication was administered on (b)(6) 2017 and the patients condition resolved in (b)(6) 2018.No coronary angiography was performed; however, computed tomography was performed on (b)(6) 2017 and noted that moderate stenosis was noted in the proximal scaffold.No additional intervention was performed to treat the restenosis.No additional information was provided.
|