Date of event: estimated.Date of implant: estimated.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The reported patient effects/treatments are consistent with the product risk profile and are therefore expected.A conclusive cause for the difficulties listed can not be determined based on the limited information available.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling literature article title "one-year results following a pre-specified absorb implantation strategy in st-elevation myocardial infarction (bvs stemi strategyit study)".The other events reported in the article are filed under separate mfr report numbers.
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It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs).Pre-dilatation was not performed in the lesion located in the mid left anterior descending coronary artery (mlad).A 2.5 x 18 mm absorb scaffold was implanted but not post dilated.Five months post scaffold implantion, target lesion revascularization was performed and another drug eluting stent bioresorbable scaffold was implanted as treatment.Details are listed in the article, titled "one-year results following a pre-specified absorb implantation strategy in st-elevation myocardial infarction (bvs stemi strategy-it study)".Specifically, this complaint was created to capture patient 5 in table 3.
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