It was reported that on (b)(6) 2013, the 3.5x18 absorb bvs was implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2017 the patient experienced chest pain, which was diagnosed as unstable angina.The patient was admitted to the hospital on (b)(6) 2017.On (b)(6) 2017 percutaneous coronary intervention (pci) with a stent was performed in the mid lad target lesion for 100% restenosis.A dissection occurred in the proximal lad and was treated with a stent.On (b)(6) 2017 there was another 100% restenosis in the mid to distal lad study lesion.This was treated with pci and resolved on (b)(6) 2017.There was no additional information provided.
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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 resorbing 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 dissection, angina, myocardial infarction and restenosis, 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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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