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

Model Number M00553520

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

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

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.(b)(4).

Event Description

It was reported to boston scientific corporation on november 18, 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, there was an issue with opening the distal flange.No patient complications were reported as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation on november 18, 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, there was an issue with opening the distal flange.No patient complications were reported as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on november 28, 2022*** it was reported that the stent was partially deployed during a biliary drainage procedure performed on (b)(6) 2022.Another axios stent was used to complete the procedure.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 fine.

Manufacturer Narrative

Blocks b3, b5, d7a, h6 (impact codes and device codes), h8 and h10 have been updated with the additional information received on november 28, 2022.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.

• 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: 15874969
• MDR Text Key: 307191977
• Report Number: 3005099803-2022-07035
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 12/27/2023
• Device Model Number: M00553520
• Device Catalogue Number: 5352
• Device Lot Number: 0029668249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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