(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex esophageal ng proximal release covered stent was implanted in the mid esophagus during a procedure performed on an unknown date to cover an esophageal perforation.According to the complainant, on (b)(6) 2019 about a week after stent implantation, a re-gastroscopy was performed and the cover of the stent was noted to be missing in some parts.The stent was removed with grasping forceps and another ultraflex esophageal stent was placed to seal the perforation.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: according to the complainant, the ultraflex esophageal ng stent was implanted to cover a perforation; however, the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.
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