It was reported that on (b)(6) 2015, a 3.0x28mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the mid left anterior descending (lad) artery and 3.5x23mm, 3.5x18mm, and 3.5x12mm scaffolds were successfully implanted in the proximal lad.On (b)(6) 2017, elevated troponin was noted.On (b)(6) 2017, the patient was admitted to the hospital for chest pain and a non-st elevated myocardial infarction (nstemi) was diagnosed.Three unspecified stents were implanted at the mid lad as treatment.There was no additional information provided regarding this issue.
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(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 and myocardial infarction, 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 the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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