Dates of event and implant: dates estimated.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.Article title: comparison of the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with st-segment elevation myocardial infarction.
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It was reported through a research article identifying an absorb scaffold that was implanted in the left anterior descending coronary artery.The patient presented with a st elevated myocardial infarction (mi).Unspecified pre-dilatation was performed, and the 2.5x23mm absorb biodegradable scaffold was implanted.A 3x23mm and 3.5x18mm absorb biodegradable scaffolds were implanted as well.Unspecified post-dilatation was performed, and the patient developed thrombosis 15 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 the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with st-segment elevation myocardial infarction.".
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