Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of restenosis and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, electronic instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported patient effects could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device malfunction referenced is filed under a separate medwatch report #.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Article titled: "serial baseline, 12-, 24-, and 60-month optical coherence tomography evaluation of st segment elevation myocardial infarction patients treated with absorb bioresorbable vascular scaffold.".
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It was reported through a research article identifying absorb bioabsorbable stents that may be related to the following: stent malposition, stenosis, thrombosis, and target vessel revascularization.Details are listed in the article, titled "serial baseline, 12-, 24-, and 60-month optical coherence tomography evaluation of st segment elevation myocardial infarction patients treated with absorb bioresorbable vascular scaffold.".
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