It was reported to boston scientific corporation that a wallflex esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date (approximately a week or two weeks prior (b)(6) 2014).According to the complainant, the stent was implanted to treat a benign post bariatric leak.On (b)(6) 2014, it was noted that the stent migrated.The physician attempted to reposition the stent when it was noted that there were 3 to 5 small diamond holes in the stent cover.The stent was removed and the procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿fine.¿.
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The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4) for the reported event of stent migration.(b)(4) for the reported event of stent cover damage.The device was not returned; therefore, a technical analysis could not be performed.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label. stent migration is listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.
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