Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported that the device was not used past its expiry date.(b)(4).The complainant indicated that the device has not been received 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.
|
It was reported to boston scientific corporation on march 15, 2019 that a wallflex esophageal partially covered stent was implanted to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was slightly tortuous and was not dilated during the initial stent placement.According to the complainant, on an unknown date, the patient presented with pain.A chest x-ray was performed and confirmed that the stent had migrated with the proximal portion of the stent still in the esophagus and the distal end of the stent impacting the stomach wall.On (b)(6) 2019, the physician attempted to remove the stent during an esophagogastroduodenoscopy (egd) procedure but it was unsuccessful due to tissue ingrowth within the stent.The physician implanted another stent inside the migrated stent to necrotize the tissue to facilitate stent removal.Reportedly, the patient experienced a pneumomediastinum.On an unknown date, both stents were successfully removed with rat tooth forceps and there were no other interventions or treatments performed to resolve the patient's pain or the pneumomediastinum.The patient was reported to be in stable condition.
|