The complainant was unable to confirm the lot number; therefore, the device manufacture and expiration dates cannot be determined.(b)(4).The complainant indicated that the device remains 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 identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation on june 02, 2017, that a cold axios stent was implanted in a transgastric position for gallbladder drainage during a procedure in (b)(6) 2012.Reportedly, the patient was considered a high surgical risk patient.The stent was properly placed in a satisfactory location, draining into the gastric posterior antrum.According to the complainant, within hours of the axios placement procedure, the patient developed peritoneal signs, which raised suspicion of a leak.The physician decided to operate on the patient.The patient underwent a cholecystectomy and intra-peritoneal bleeding was reported.The physician reported that the bleeding was not related to the axios stenting procedure as no bleeding was observed during the endoscopic procedure; the bleeding was considered related to surgery.The patient remained hospitalized and died approximately 1 month after surgery.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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