(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 effect of restenosis, 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 there is no indication of a product quality issue with respect to manufacture, design or labeling.The other absorb bvs referenced in is filed under a separate medwatch report number.
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It was reported that on (b)(6) 2013, a 3.0x12mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the mid left anterior descending (lad) coronary artery lesion and a 3.0x12mm scaffold was successfully implanted in the distal right coronary artery (rca) lesion.On (b)(6) 2016, the patient was hospitalized.Two percutaneous procedures were performed, placing an unspecified stent in the 90% restenosed mid lad and the 50% restenosed distal rca.There were no clinical symptoms due to the event.The event resolved without sequela and the patient was discharged from the hospital on (b)(6) 2016.There was no additional information provided.
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