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

Model Number	M00553690
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	Biliary Leak (4820)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the bile duct for the treatment of a metastatic cholangiocarcinoma during a choledocho duodenostomy procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed, and the handle broke.The device was removed, and the puncture was closed using an ovesco clip.The patient experienced bile leak and was admitted to the hospital beyond standard of care.Endoscopic retrograde cholangiopancreatography (ercp) procedure was performed to address the bile leak and a fully covered biliary metal stent was placed in the common bile duct.The patient was discharged from the hospital two weeks later.Note: it was reported that the axios stent was intended to be placed in the blie duct to treat a metastatic cholangiocarcinoma.However, per the axios stent and electrocautery- enhanced delivery system instructions for use, 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 to be placed in the bile duct.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent failed to deploy for biliary indication.Imdrf device code a0401 captures the reportable event of handle break for biliary indication.Imdrf patient code e1108 captures the reportable event of bile leak.Imdrf impact code f2202 captures the reportable event of the endoscopic procedure performed to address the bile leak.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the bile duct for the treatment of a metastatic cholangiocarcinoma during a choledocho duodenostomy procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed, and the handle broke.The device was removed, and the puncture was closed using an ovesco clip.The patient experienced bile leak and was admitted to the hospital beyond standard of care.Endoscopic retrograde cholangiopancreatography (ercp) procedure was performed to address the bile leak and a fully covered biliary metal stent was placed in the common bile duct.The patient was discharged from the hospital two weeks later.Note: it was reported that the axios stent was intended to be placed in the bile duct to treat a metastatic cholangiocarcinoma.However, per the axios stent and electrocautery- enhanced delivery system instructions for use, 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 to be placed in the bile duct.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent failed to deploy for biliary indication.Imdrf device code a0401 captures the reportable event of handle break for biliary indication.Imdrf patient code e1108 captures the reportable event of bile leak.Imdrf impact code f2202 captures the reportable event of the endoscopic procedure performed to address the bile leak.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Block h11: an axios stent and electrocautery enhanced delivery system were returned for analysis.The stent was returned partially deployed.Visual examination of the returned device found the control hub detached from the outer sheath.The inner sheath was also kinked.No other problems were noted with the stent and delivery system.The investigation concluded that the observed problem of control hub detached from the outer sheath was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and/or the technique used by the physician (force applied), limited the performance of the device and contributed to the observed problem.The reported event of stent failure to deploy was confirmed as the stent was received partially deployed.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the device was intended to be placed in the bile duct to treat a metastatic cholangiocarcinom.The ifu states, "the axios stent and electrocautery-enhanced delivery system instructions for use, 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 axios stent is not indicated to be implanted in the bile duct.Additionally, stent partially deployed is a known potential complication associated with the use of the device in the manufacturer's labeling.Taking all available information into consideration, the investigation concluded that the most probable root cause is known inherent risk of device.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19655180
• Report Number: 3005099803-2024-03137
• Device Sequence Number: 6596028
• Product Code: PCU
• UDI-Device Identifier: 00191506008093
• UDI-Public: 00191506008093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2025
• Device Model Number: M00553690
• Device Catalogue Number: 5369
• Device Lot Number: 0032554961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown