Date of event, implant date: estimated dates.Exemption number (b)(4).The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.Literature attachment: ¿a paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the aida trial¿.
|
It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to the following: myocardial infarction, target lesion/vessel revascularization, and scaffold/stent thrombosis.For additional information, please see attached article ¿a paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the aida trial¿.
|
The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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 thrombosis and myocardial infarction, are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use as known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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 design, manufacture or labeling of the device.
|