There was no reported device malfunction and the product was not returned.A review of the lot history record for the reported lot could not be conducted because the part and lot numbers were not provided.The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use (ifu) as known adverse events associated with the use of a coronary scaffold.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 the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Title: comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trialna.
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It was reported through a research article identifying an absorb scaffold that was implanted in the distal circumflex coronary artery.The patient presented with angina.Pre-dilatation was performed with an unspecified 3x15mm balloon at 18 atmospheres (atms), and the 3x18mm absorb biodegradable scaffold was implanted at 12 atms.Post-dilatation was not performed.The patient developed thrombosis and a myocardial infarction (mi) 427 days later.Type of treatment was not specified.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.".
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