The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture 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 (b)(6) 2021 that an agile esophageal stent was implanted in the lower esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During a scheduled check up per protocol on (b)(6) 2021, the stent migrated from the lower esophagus to the stomach.The stent was removed from the patient using rat tooth forceps and the physician notes that the stricture was half resolved.There were no patient complications as a result of this event.
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