(b)(4).According to the complainant, the suspect device remained 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 received, a supplemental mdr will be filed.
|
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex esophageal fully covered stent has been implanted to treat a malignant stricture in the mid section and lower part of the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, on (b)(6) 2018, during a routine follow-up, endoscopic retrograde cholangiopancreatography (ercp) procedure was performed to reexamine the stent and noticed the stent had migrated into the stomach.A snare was used to reposition the stent back to its original location.Per the physician, the stent does not need to be retrieved out from the patient.There were no patient complications reported as a result of this event.Reportedly, the stricture had resolved when the stent migrated.
|