Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility and prolapse; however, the subsequent serious injury/ illness/ impairment appears to be related to the operational context of the procedure.The reported patient effect of prolapse is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Date of event estimated (b)(6) 2020.The udi is unknown due to the part/lot number was not provided.Implant date estimated: (b)(6) 2019.Literature article title: preferable vascular healing of ultrathin strut biodegradable-polymer sirolimus-eluting stents in patients with acute coronary syndrome the xience sierra device referenced is filed under a separate medwatch report number.
|
The study investigated strut coverage comparison between non-abbott orsiro ultrathin struts biodegradable polymer sirolimus-eluting stents (o-ses) and xience alpine and xience sierra everolimus-eluting stents (x-ees), using the dragonfly catheter optical coherence tomography (oct), eight months post implantation.The following complications were noted: uncovered stent struts and mal-apposed stent struts and irregular protrusion.A few patients were excluded from the study due to poor quality images with the dragonfly.The study concluded o-ses showed higher percentage of the covered struts compared to x-eess, at eight month oct follow-up.Specific patient information is documented as unknown as this is from an article summary.Details are listed in the attached article, titled " preferable vascular healing of ultrathin strut biodegradable polymer sirolimus eluting stents in patients with acute coronary syndrome.".
|