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

Model Number M00553560

Device Problems Use of Device Problem (1670); Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on july 10, 2023 that an axios stent and electrocautery-enhanced delivery system was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure performed on (b)(6) 2023.During the procedure, after puncturing the jejunal loop and deploying the stent's first flange, it was noticed that the first flange was unable to expand.When the second flange was deployed, the stent jumped into the peritoneum.The stent was removed surgically and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure.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 a pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed endoscopic retrograde cholangiopancreatography (ercp) in patients with biliary obstruction due to a malignant stricture.The device is not indicated for placement in the jejunum and for the treatment of malignant gastric outlet obstruction.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 instructions for use (ifu) states, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." the physician did not follow the steps cited in the ifu.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code 1502 captures the reportable event of stent positioning issue.Imdrf impact code f19 captures the surgical intervention performed to close the puncture site and remove the stent.

Event Description

It was reported to boston scientific corporation on july 10, 2023 that an axios stent and electrocautery-enhanced delivery system was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure performed on (b)(6) 2023.During the procedure, after puncturing the jejunal loop and deploying the stent's first flange, it was noticed that the first flange was unable to expand.When the second flange was deployed, the stent jumped into the peritoneum.The stent was removed surgically and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure.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 a pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed endoscopic retrograde cholangiopancreatography (ercp) in patients with biliary obstruction due to a malignant stricture.The device is not indicated for placement in the jejunum and for the treatment of malignant gastric outlet obstruction.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 instructions for use (ifu) states, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." the physician did not follow the steps cited in the ifu.**additional information received on august 02, 2023** a gastrojejunostomy procedure was performed to complete the procedure.

Manufacturer Narrative

Blocks b5 and h6 (impact codes) has been updated with additional information received on august 02, 2023.Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code 1502 captures the reportable event of stent positioning issue.Imdrf impact code f19 captures the surgical intervention performed to close the puncture site and remove the stent.

Event Description

It was reported to boston scientific corporation on july 10, 2023 that an axios stent and electrocautery-enhanced delivery system was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure performed on (b)(6) 2023.During the procedure, after puncturing the jejunal loop and deploying the stent's first flange, it was noticed that the first flange was unable to expand.When the second flange was deployed, the stent jumped into the peritoneum.The stent was removed surgically and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure.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 a pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed endoscopic retrograde cholangiopancreatography (ercp) in patients with biliary obstruction due to a malignant stricture.The device is not indicated for placement in the jejunum and for the treatment of malignant gastric outlet obstruction.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 instructions for use (ifu) states, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." the physician did not follow the steps cited in the ifu.**additional information received on august 02, 2023** a gastrojejunostomy procedure was performed to complete the procedure.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code 1502 captures the reportable event of stent positioning issue.Imdrf impact code f19 captures the surgical intervention performed to close the puncture site and remove the stent.Block h10: an axios stent and electrocautery-enhanced delivery system were received for analysis.The stent was received fully deployed and expanded.Visual inspection found the inner sheath kinked.Destructive inspection was performed, and the delivery system was disassembled to identify the torsion (rotational damage), and no problems were found.No other problems with the stent and delivery system were noted.Product analysis did not confirm the reported event of stent first flange failure to expand because the stent was received fully expanded.Furthermore, the reported event of stent positioning issue was also not confirmed because the event occurred during the procedure and is not possible to replicate in the laboratory of analysis.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) could have resulted in the observed event of inner sheath kinked.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.It was reported that the handle was rotated as the device was luer locked to the scope.However, the ifu states, "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." additionally, the complainant reported that the axios stent was to be implanted in the jejunum to treat a malignant gastric outlet obstruction during an endoscopic ultrasound (eus) guided gastrojejunostomy procedure.The ifu states, "the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed endoscopic retrograde cholangiopancreatography (ercp) in patients with biliary obstruction due to a malignant stricture." lastly, stent positioning issue is noted within the ifu as a potential adverse event associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.

• 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: 17432735
• MDR Text Key: 320117019
• Report Number: 3005099803-2023-04041
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K220112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0031416275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/02/2023; 01/12/2024
• Supplement Dates FDA Received: 08/23/2023; 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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
• Patient Sex: Male
• Patient Race: Asian