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

Model Number M00553550

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

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

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted in the pancreas to treat an acute biliary pancreatitis during a stent placement procedure performed on (b)(6) 2022.During the procedure, the axios stent was not completely released, as a result, the physician was unable to visualize the device and ensure correct drainage.Subsequently, the axios stent was removed and another axios stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the hot axios stent was to be implanted to treat an acute biliary pancreatitis.Per the instructions for use (ifu), "the hot axios stent and electrocautery- enhanced delivery system 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 ercp in patients with biliary obstruction due to a malignant stricture".The stent is not indicated for the treatment of acute biliary pancreatitis.

Manufacturer Narrative

Blocks b1, b2 (outcomes attrib to adv event), b5, h1, h6 (device codes) based on the additional information received on december 07, 2022.Block h6: imdrf device code a150101 captures the reportable event of axios stent failure to expand.

Event Description

It was reported to boston scientific corporation on november 09, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted in the pancreas to treat an acute biliary pancreatitis during a stent placement procedure performed on (b)(6) 2022.During the procedure, the axios stent was not completely released, as a result, the physician was unable to visualize the device and ensure correct drainage.Subsequently, the axios stent was removed and another axios stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the hot axios stent was to be implanted to treat an acute biliary pancreatitis.Per the instructions for use (ifu), "the hot axios stent and electrocautery- enhanced delivery system 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 ercp in patients with biliary obstruction due to a malignant stricture".The stent is not indicated for the treatment of acute biliary pancreatitis.The axios stent was to be implanted transgastric to pancreas.During the procedure, there was no resistance during stent deployment and the stent got deployed; however, the stent was unable to completely open and could not be visualized due to the necrotic tissue.The axios stent was removed with forceps clamp.

Manufacturer Narrative

Blocks b5 and h6 (device codes) based on the additional information received on december 30, 2022.Block h6: imdrf device code a150101 captures the reportable event of axios stent failure to expand.

Event Description

It was reported to boston scientific corporation on november 09, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted in the pancreas to treat an acute biliary pancreatitis during a stent placement procedure performed on (b)(6) 2022.During the procedure, the axios stent was not completely released, as a result, the physician was unable to visualize the device and ensure correct drainage.Subsequently, the axios stent was removed and another axios stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the hot axios stent was to be implanted to treat an acute biliary pancreatitis.Per the instructions for use (ifu), "the hot axios stent and electrocautery- enhanced delivery system 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 ercp in patients with biliary obstruction due to a malignant stricture".The stent is not indicated for the treatment of acute biliary pancreatitis.**additional information received on december 07, 2022** the axios stent was to be implanted transgastric to pancreas.During the procedure, there was no resistance during stent deployment and the stent got deployed; however, the stent was unable to completely open and could not be visualized due to the necrotic tissue.The axios stent was removed with forceps clamp.**additional information received on december 30, 2022** it was reported that the axios stent was indicated for the treatment of pancreatic cys and the necrotic tissue was part of the cyst.

• 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: 15900078
• MDR Text Key: 307886548
• Report Number: 3005099803-2022-06979
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

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: 01/05/2024
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0028626585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/07/2022; 12/30/2022
• Supplement Dates FDA Received: 12/27/2022; 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG