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

Model Number M00553640

Device Problems Break (1069); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Purulent Discharge (1812)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a15 capture the reportable event of stent partial deployment.Imdrf patient code e1108 captures the reportable patient complication of biliary leak.Imdrf patient code e231501 captures the reportable patient complication of purulent discharge.Imdrf impact code f2303 is being used to capture the medication administered to prevent infection.Imdrf impact code f2301 is being used to capture the additional device used to attempt to deploy stent's second flange and the clips used to close the puncture site.

Event Description

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # and 3005099803-2023-05658 for the associated device information.It was reported to boston scientific corporation that two axios stents and an electrocautery enhanced delivery system were to be implanted transgastrically into the gallbladder to treat a gallbladder infection during a gallbladder drainage procedure performed on (b)(6), 2023.During the procedure, when the first axios stent's first flange (the subject of this report) was attempted to be deployed, the gray stent deployment hub was difficult to pull up and it broke and fell off of the handle.An attempt was made to deploy the stent's second flange using hemostat graspers, but it was unsuccessful, so the stent removed from the patient partially deployed on the delivery system.A second axios stent (the subject of mfr.Report # 3005099803-2023-05658) was opened, but it was not able to advance through the patient's anatomy.The puncture site was then closed using clips, and the procedure was not completed.The patient experienced bile and pus leakage at the puncture site into the peritoneal cavity, so the physician administered prophylactic antibiotics to prevent infection.The patient was reported to have been fully recovered.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was used for gallbladder drainage to treat a gallbladder infection.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 and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall.The stent is not indicated for gallbladder drainage to treat a gallbladder infection.It was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

Event Description

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-05657 and 3005099803-2023-05658 for the associated device information.It was reported to boston scientific corporation that two axios stents and an electrocautery enhanced delivery system were to be implanted transgastrically into the gallbladder to treat a gallbladder infection during a gallbladder drainage procedure performed on (b)(6) 2023.During the procedure, when the first axios stent's first flange (the subject of this report) was attempted to be deployed, the gray stent deployment hub was difficult to pull up and it broke and fell off of the handle.An attempt was made to deploy the stent's second flange using hemostat graspers, but it was unsuccessful, so the stent removed from the patient partially deployed on the delivery system.A second axios stent (the subject of mfr.Report # 3005099803-2023-05658) was opened, but it was not able to advance through the patient's anatomy.The puncture site was then closed using clips, and the procedure was not completed.The patient experienced bile and pus leakage at the puncture site into the peritoneal cavity, so the physician administered prophylactic antibiotics to prevent infection.The patient was reported to have been fully recovered.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was used for gallbladder drainage to treat a gallbladder infection.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 and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall.The stent is not indicated for gallbladder drainage to treat a gallbladder infection.It was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.

Manufacturer Narrative

Block h6: imdrf device code a15 capture the reportable event of stent partial deployment.Imdrf patient code e1108 captures the reportable patient complication of biliary leak.Imdrf patient code e231501 captures the reportable patient complication of purulent discharge.Imdrf impact code f2303 is being used to capture the medication administered to prevent infection.Imdrf impact code f2301 is being used to capture the additional device used to attempt to deploy stent's second flange and the clips used to close the puncture site.Block h10: the axios stent and electrocautery enhanced delivery system were received for analysis.Visual inspection found that the stent was partially deployed from the delivery system, the outer sheath was kinked, and the stainless-steel tubing for the pusher catheter was detached from the handle.The control hub was not returned with the device.Functional analysis related to the deployment of the stent was not performed due to the condition of the returned device (broken handle).Destructive analysis was performed to identify the torsion (rotational damage), and it was found that the outer sheath was not twisted.Product analysis confirmed the reported events of handle break and stent partial deployment.The investigation concluded that the reported event of stent partial deployment was considered a known adverse event related to the use of the device and was documented in the labeling, and all reasonable steps have been taken, including both short- and long-term known complications.It was further concluded that the reported event of a handle break and the additional investigation findings of sheath kink and system damage were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) that could have resulted in the damages found in the device.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the axios stent and electrocautery-enhanced delivery system was used for gallbladder drainage to treat a gallbladder infection.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 and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall.The stent is not indicated for gallbladder drainage to treat a gallbladder infection.Additionally, it was reported that the handle was rotated as the device was luer-locked to the scope.The axios stent and electrocautery enhanced delivery system directions for use state, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18002321
• MDR Text Key: 326457188
• Report Number: 3005099803-2023-05657
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN230019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: M00553640
• Device Catalogue Number: 5364
• Device Lot Number: 0029134448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention