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 01/15/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted in the transgastric-jejunal loop to treat a malignant gastric outlet obstruction (goo) during an endoscopic ultrasound-guided gastrojejunostomy (eus-gj) procedure performed on (b)(6) 2024.The physician was using the eus method of deployment where the second flange of the stent was deployed in the scope, and then the stent was released from the scope by advancing the catheter and retracting the scope in a 1-to-1 fashion.During the procedure, the jejunal loop was punctured, and the axios stent first flange was deployed, but it did not fully expand and was not properly apposed to the tissue.The second flange was deployed, but the axios stent jumped into the "peritoneum".The procedure was not completed due to this event.The patient was sent for surgery to remove the stent; however, there were no patient complications reported as a result of this event.Note: it was reported that the axios stent and electrocautery- enhanced delivery system was used to treat a malignant gastric outlet obstruction (goo) in the jejunal loop during an endoscopic ultrasound-guided gastrojejunostomy (eus-gj) procedure.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, the gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture.The stent is not indicated for a malignant gastric outlet obstruction in the jejunal loop during an endoscopic ultrasound-guided gastrojejunostomy (eus-gj) procedure.It was further 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 state "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of the stent's first flange failure to expand.Imdrf device code a1502 captures the reportable event of the stent positioning issue.Imdrf impact code f19 captures the surgical intervention to remove the stent.Imdrf impact code f1001 captures the canceled/rescheduled 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: 18652950
• MDR Text Key: 334688760
• Report Number: 3005099803-2024-00296
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0032006947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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: Female