BOSTON SCIENTIFIC - COSTA RICA (COYOL) AXIOS STENT AND DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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Model Number M00553550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Stenosis (2263)
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Event Type
Injury
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Manufacturer Narrative
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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 suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a hot axios stent was implanted in the common bile duct (cbd) during a choledochoduodenostomy procedure performed on an unknown date.According to the complainant, in the days after the stent placement procedure, the patient presented with significant pain.Reportedly, the patient had developed cholangitis and a duodenal stricture in the region of the stent placement.Reportedly, the physician is unsure of the exact association between these events and the axios stent.It was also reported that the stent remains implanted.There were no further patient complications reported as a result of this event.The patient's condition was reported to be stable.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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