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

Model Number M00553550

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the pancreas to treat a walled off pancreatic necrosis (wopn) during a drainage procedure performed on (b)(6), 2023.During the procedure, the second flange prematurely deployed outside the scope.The stent was deployed in the correct location, and the abscess cavity was drained.The procedure was completed using the original stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.Block h10: an axios electrocautery enhanced delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the control hub separated/detached from the handle and the inner sheath kinked.No other problems were noted to the delivery system.The observed failures of control hub separated/detached from the handle and inner sheath kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the observed failures.The reported event of stent premature deployment cannot be confirmed as this occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Based on the available information, there is not enough information to confirm the reported event of stent premature deployment; 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, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the pancreas to treat a walled off pancreatic necrosis (wopn) during a drainage procedure performed on (b)(6) 2023.During the procedure, the second flange prematurely deployed outside the scope.The stent was deployed in the correct location, and the abscess cavity was drained.The procedure was completed using the original stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 17825115
• MDR Text Key: 324361442
• Report Number: 3005099803-2023-05187
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0031356949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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