Date of event, implant date: estimated dates.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of occlusion is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device malfunction referenced is being filed under a separate medwatch report#.Article, titled: a randomised comparison of healing response between the buma supreme stent and the xience stent at one-month and two-month follow-up: pioneer-ii oct randomised controlled trial.
|
It was reported through a research article identifying unknown xience stents that may be related to the following: malposition, hyperplasia, obstruction, restenosis, and late lumen loss.Specific patient information is documented as unknown.Details are listed in the attached article, titled: a randomised comparison of healing response between the buma supreme stent and the xience stent at one-month and two-month follow-up: pioneer-ii oct randomised controlled trial.
|