The complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(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 march 26, 2021 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal perforation during a stent placement procedure performed on (b)(6) 2021.The patient had a 2 mm puncture from external erosion of a granuloma into the esophagus.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was successfully deployed in the correct location.However, it was noted that the stent did not seal the perforation and fluid was going through the stent and out the esophageal perforation.The physician attempted to reposition the stent but there still appeared to be a leak.The stent was removed from the patient with forceps, and another wallflex esophageal stent was implanted to complete the procedure.Reportedly, the physician noticed a small tear in the stent cover.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex esophageal partially covered stent was used to seal an esophageal perforation.Per wallflex esophageal partially covered stent system directions for use (dfu), the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The stent is not indicated to treat esophageal perforation.
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