Outcomes attributed to adverse event, date of event, implant date: dates estimated.The additional adverse patient effects and device malfunctions referenced will be filed under separate medwatch report #s.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.A definitive cause for the reported death and the relationship to the product, if any, cannot be determined.The reported patient effect of death is listed in the supera instruction for use as a known potential patient effect associated with the use of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.Article title: a midterm analysis of patients who received femoropopliteal helical interwoven nitinol stents.
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It was reported through a research article identifying supera that may be related to the following: patient death, restenosis, occlusion, pseudoaneurysm, elongation, malposition, amputation, revascularization, and rehospitalization.This article summarizes clinical outcomes of 315 patients that were treated with supera stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "a midterm analysis of patients who received femoropopliteal helical interwoven nitinol stents.".
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