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

Model Number M00553660

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Activation Failure (3270)

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

Event Date 02/19/2024

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 transgastric to the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) with cystgastrostomy procedure performed on (b)(6) 2024.During the procedure, the stent's first flange was deployed, but it was unable to expand.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another axios stent of a different size.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted transgastric to the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) with cystgastrostomy procedure performed on february 19, 2024.During the procedure, the stent's first flange was deployed but it was unable to expand.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another axios stent of a different size.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h10: an axios stent and electrocautery-enhanced delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the inner sheath kinked.Media inspection was performed on the photo of the device provided, and it was observed that the stent's first flange was unable to expand.During functional inspection, the stent hub was moved down to the second and fourth position, and the stent was deployed and fully expanded.Dimensional inspection found the stent within specification.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent first flange failure to expand.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, the observed event of stent partially deployed is noted within the ifu as a potential adverse event associated with the use of the device.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician resulted in the observed event of inner sheath kinked and the reported event of stent first flange failure to expand.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to 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: 18895122
• MDR Text Key: 337678725
• Report Number: 3005099803-2024-00973
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K233318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0033035798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2023
• 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