(b)(4).The complainant indicated that the device was contaminated 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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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02156.For the associated device information.It was reported to boston scientific corporation on (b)(6) 2020 that two wallflex esophageal partially covered stents were to be used to treat a 7cm extrinsic stricture in the lower esophageal sphincter during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the first wallflex esophageal stent (the subject of mfr.Report # 3005099803-2020-02156) had difficulty in crossing the anatomy and was unable to be deployed.Upon removal of the stent delivery system, it was noticed that the white olive tip was bent.A second wallflex esophageal stent (the subject of this report) was used, however, the same issues occured and the white olive tip was again bent.Reportedly, the physician called off any further treatment.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 stable.
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