Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant: estimated.The devices were not returned for analysis.A review of the lot history records and complaint histories could not be conducted because the lot and part numbers were not provided.The patient effects listed 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.The other patient events noted in the article are filed under separate medwatch report numbers.
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This is filed to report the serious injuries: it was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to the following: cardiac death, target-vessel myocardial infarction, ischemia driven target lesion re-vascularization, bleeding and thrombosis.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)".
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