The complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device remains implanted 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 a wallflex esophageal partially covered stent had been implanted to treat a malignant stricture in the distal esophagus during a stent placement procedure performed on (b)(6) 2018.After stent placement, the patient's cancer was treated with chemotherapy and radiation.According to the complainant, on (b)(6) 2019, the patient presented with pain, nausea and regurgitation.An esophagogastroduodenoscopy (egd) procedure was performed to examine the stent, and during the procedure, it was observed that the stent was patent and appeared to be in good position.The stent remains implanted and the physician didn't note any issues with the stent.Per the physician, the patient's pain was not related to the stent and the patient didn't have any change in pain related to the stent.In the physician's opinion, the nausea and vomiting were probably due to uncontrolled reflux post stent placement.The patient was treated with zofran, reglan and a high dose of ppi (proton pump inhibitor) to relieve nausea and vomiting as prescribed by the physician.Reportedly, the patient's current condition was reported to be fine but the nausea and vomiting has not yet resolved.
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