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 effect listed is consistent with the product risk profile and is therefore expected.A conclusive cause for the reported death 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 additional adverse patient effects referenced are being filed under a separate medwatch report number.The additional xience device referenced is being filed under a separate medwatch report#.The udi is unknown because the part and lot #s were not provided.Article: "angiographic and clinical outcomes of stemi patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data.".
|
It was reported through a research article identifying absorb and xience that may be related to the following: death, thrombosis, revascularization, and myocardial infraction.Specific patient information is documented as unknown.Details are listed in the article, titled: angiographic and clinical outcomes of stemi patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data.
|