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

Model Number M00553540

Device Problems Material Deformation (2976); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: the reported healthcare facility is: (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, the first flange of the stent was released; however, it did not expand.A photo of the complaint device was provided, and the stent was fully deployed, and the inner sheath was kinked.It is unknown if the stent was fully deployed inside the patient to facilitate removal.The procedure was completed using another axios stent.There were no patient complications 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 that an axios stent and electrocautery enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, the first flange of the stent was released; however, it did not expand.A photo of the complaint device was provided, and the stent was fully deployed, and the inner sheath was kinked.It is unknown if the stent was fully deployed inside the patient to facilitate removal.The procedure was completed using another axios stent.There were no patient complications 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.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: the reported healthcare facility is: (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.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 inner sheath kinked.A media inspection was performed on a photo provided by the complainant, and it was found that the stent was fully deployed and expanded.No other problems were noted to the delivery system.Taking all available information into consideration, the investigation concluded that the observed damage of inner sheath kinked was 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 damage.The reported event of stent positioning issue is a known potential complication associated with the use of the device in the manufacturer's labeling.The reported event of stent failure to expand cannot be confirmed as the stent was fully deployed and expanded; 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 placement is noted within the manufacturer's labeling as a known possible adverse event related to the use of the device.

• 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: 18878194
• MDR Text Key: 337406575
• Report Number: 3005099803-2024-00958
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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 Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0031160809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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
• Patient Outcome(s): Required Intervention