(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.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 infarction and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) 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.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) 2015, the patient presented with unstable angina.A 3.0x28mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the mid right coronary artery (rca) lesion.On (b)(6) 2016, the patient was hospitalized with chest pain, elevated cardiac enzymes, atrial fibrillation (a-fib), and a non-st elevated myocardial infarction (nstemi) was diagnosed.Diagnostic coronary angiography showed in scaffold restenosis <30%.Medications and thrombolytic treatment were provided.The event resolved without sequela and on (b)(6) 2016, the patient was discharged from the hospital.There was no additional information provided.
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