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

Model Number M00553650

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978); Positioning Problem (3009); Poor Visibility (4072)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on october 26, 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a pancreatic cyst with 20 percent necrotic material during a pancreatic cyst drainage procedure performed on (b)(6) 2022.During the procedure, the axios stent was deployed, and drainage was observed; however, it was not visible under eus that the flange was completely opened.The physician then pulled the delivery system thinking that the axios stent was deployed without issue and checked the stent placement.Upon removal of the scope, it was noted that the stent was fully deployed inside the scope and the tip/nose cone was noted to be damaged.The procedure was completed using a different stent.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a04 captures the reportable event of tip damaged.Block h10: an axios stent and electrocautery enhanced delivery system were returned for analysis.The stent was returned fully deployed and expanded.Visual examination of the returned device found the stent cover damaged at the wall section.The inner sheath was kinked, the nose cone (tip) was detached and was not returned, and the copper wire was detached.No other problems were noted to the stent and delivery system.The reported events of stent positioning issue, device entrapment of device or device component and stent not visible under eus or fluoroscopy occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.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 stent placement is noted within the instructions for use (ifu) as a known potential adverse event related to the use of the device.Taking all available information into consideration, the investigation concluded that the reported event and observed failures were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, the technique used by the physician and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the reported event and the observed failures.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a pancreatic cyst with 20 percent necrotic material during a pancreatic cyst drainage procedure performed on (b)(6), 2022.During the procedure, the axios stent was deployed, and drainage was observed; however, it was not visible under eus that the flange was completely opened.The physician then pulled the delivery system thinking that the axios stent was deployed without issue and checked the stent placement.Upon removal of the scope, it was noted that the stent was fully deployed inside the scope and the tip/nose cone was noted to be damaged.The procedure was completed using a different stent.There were no patient complications 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: 15807901
• MDR Text Key: 303830175
• Report Number: 3005099803-2022-06698
• 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: K153088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0028510641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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