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

Model Number M00553650

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 10/19/2023

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 pancreas to treat a pancreatic cyst due to acute pancreatitis during a pancreatic cyst gastric (intestinal) bypass procedure performed on (b)(6) 2023.During the procedure, the stent first flange was deployed.However, it was noted under echographic images that it did not expand.The physician continued to deploy the stent.However, after fully deploying the stent, it was noted that the stent moved out of its position and into the stomach.The 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.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).H6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150101 captures the reportable event of stent first flange failure to expand.

Manufacturer Narrative

Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h10: an axios electrocautery enhanced delivery system was received for analysis; the stent was not returned.The delivery system was inspected, and no damages were noted.The reported events of stent first flange failure to expand and stent positioning issue cannot be confirmed.Based on the available information, there is not enough information to confirm the reported events; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, improper axios stent placement is noted within the ifu as possible adverse event associated with the use of the device.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted in the pancreas to treat a pancreatic cyst due to acute pancreatitis during a pancreatic cyst gastric (intestinal) bypass procedure performed on (b)(6) 2023.During the procedure, the stent first flange was deployed; however, it was noted under echographic images that it did not expand.The physician continued to deploy the stent; however, after fully deploying the stent, it was noted that the stent moved out of its position and into the stomach.The 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.

• 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: 18095197
• MDR Text Key: 327666794
• Report Number: 3005099803-2023-06131
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0031557858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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