MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2015

Event Type  Death  

Event Description

Boston scientific became aware of an event involving an axios stent and electrocautery enhanced delivery system through the article, single-stage eus-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction, by andrea anderloni, et al.Per the article, between october 2015 and april 2018, axios stent and electrocautery enhanced delivery system lumen-apposing metal stents (lams) were implanted.46 patients (47.8% women; median age, 73.1 +/- 12.6 years) underwent eus-guided choledochoduodenostomy (eus-cd) for inoperable malignant distal bile duct obstruction.All the eus procedures were performed with the patient under deep sedation with propofol and using carbon dioxide for insufflation.Procedures were performed in an endoscopy room equipped with fluoroscopy.All procedures were done by an endoscopist with experience in eus and electrocautery-enhanced (ec)-lams drainage.The bile duct was localized by eus from the duodenal bulb.The ec-lams catheter was then inserted into the working channel of the echoendoscope and secured to the inlet port of the working channel.The delivery system was connected to the electrosurgical generator.The catheter was positioned tangentially to the bile duct and introduced into the duct with application of cautery, under eus guidance.After the catheter was fully inside the target structure, the first flange of the stent was deployed under eus view.After eus confirmation of the correct position of the device inside the bile duct, the catheter was slightly withdrawn to create wall apposition, followed by deployment of the second end of the stent using the intrachannel release technique.The endoscope was then gently withdrawn while the catheter control hub was slowly advanced to allow for the release of the second flange from the working channel of the echoendoscope.All patients were followed up daily until discharge, after which they were evaluated 30 days after discharge and every 3 months until their death.Technical success occurred in 43 patients, which was defined as the placement of an ec-lams in the extrahepatic bile duct in a single-step approach.Clinical success was defined as a decrease in serum bilirubin level of 50% or more within 2 weeks after the procedure of biliary drainage.An adverse event occurred in one patient who had a preoperative multi-organ failure and underwent successful ec-lams placement.The patient experienced duodenal arterial bleeding and died 17 days after the procedure.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.Approximated based on the month and year the first procedures were performed.Blocks d4 and h4: the complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Block g2 literature source: anderloni a.Et al."single-stage eus-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction".Gastrointest endosc.2018; 89(1):69-76.Doi: 10.1016/j.Gie.2018.08.047.Block h6: patient code e0506 captures the reported duodenal arterial bleeding.Impact code f02 captures the reported death.Block h10: the axios stent and electrocautery enhanced delivery system was not received for analysis.However, a media analysis was performed, which identified the stent inside the patients anatomy.Based on the available information, this axios stent remains implanted.As such, physical analysis has not been conducted in our laboratory.The investigation concluded that the reported events of hemorrhage, major, and death are known and documented in the labeling; therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17740914
• MDR Text Key: 323332806
• Report Number: 3005099803-2023-04878
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death