BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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Model Number M00553690 |
Device Problems
Use of Device Problem (1670); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a1502 captures the reportable event of stent first flange difficult to position.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2023 that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to common bile duct to treat a cholechoduodenostomy during an endoscopic ultrasound (eus) with stent placement procedure performed on an unknown date.The physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion.During the procedure, the stent's first flange was deployed incorrectly into the peritoneal cavity.The axios stent was partially deployed when it was removed from the patient.The procedure was not completed as the physician felt unsafe to proceed.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was to be implanted for choledochoduodenostomy.However, per the axios stent and electrocautery- enhanced delivery system instructions for use (ifu), the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris.The device is not indicated for choledochoduodenostomy.
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Search Alerts/Recalls
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