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

Model Number M00553660

Device Problems Failure to Conduct (1114); Difficult or Delayed Positioning (1157); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Poor Visibility (4072)

Patient Problem Perforation (2001)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that an axios stent and electrocautery enhanced delivery system was to be implanted to treat a duodenal obstruction during a gastrojejunostomy with stent placement procedure performed on (b)(6) 2023.During the procedure, there was difficulty in deploying the stent and the device was unable to deliver energy.It was also reported that the stent was deployed in an incorrect location and was not visible under fluoroscopy.Furthermore, the patient encountered perforation.It is not known how the perforation was addressed.The axios stent was removed and the procedure was reported to be completed successfully.Note: it was reported that the axios stent and electrocautery enhanced delivery system was to be implanted to treat a duodenal obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery- enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with > 70% fluid content or the biliary tract." the stent is not indicated for the treatment of duodenal obstruction.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: patient code e2114 captures the reportable event of perforation.Imdrf device code a1502 captures the reportable event of axios stent positioning issue.Block h10: the device was disposed and will not be returned for analysis; therefore, a technical analysis could not be performed.However, a photo of the device was provided by the complainant and it was observed that the hub/luer was detached.No other visible problems were noted on the photo provided.Media analysis could not confirm the reported events of stent difficult to deploy, stent positioning issue, cautery failure to deliver energy, and stent not visible under eus or fluoroscopy as these events occurred during the procedure and there is not an objective evidence or descriptive condition to confirm the reported events.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the axios stent and electrocautery enhanced delivery system was to be implanted to treat a duodenal obstruction.The ifu states, "the axios stent and electrocautery- enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with > 70% fluid content or the biliary tract." additionally, improper axios stent placement and perforation are noted within the ifu as a potential adverse events associated with the use of the device.There is not enough evidence to determine whether the reported and observed events were due to the physician's technique or due to the procedural and anatomical conditions during the reported event, or whether it was related to a device malfunction during the procedure.The investigation findings did not lead to a clear conclusion about the cause of the reported event; without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable root cause of the event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.

Event Description

It was reported to boston scientific corporation on january 19, 2023 that an axios stent and electrocautery enhanced delivery system was to be implanted to treat a duodenal obstruction during a gastrojejunostomy with stent placement procedure performed on (b)(6) 2023.During the procedure, there was difficulty in deploying the stent and the device was unable to deliver energy.It was also reported that the stent was deployed in an incorrect location and was not visible under fluoroscopy.Furthermore, the patient encountered perforation.It is not known how the perforation was addressed.The axios stent was removed and the procedure was reported to be completed successfully.Note: it was reported that the axios stent and electrocautery enhanced delivery system was to be implanted to treat a duodenal obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery- enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with > 70% fluid content or the biliary tract." the stent is not indicated for the treatment of duodenal obstruction.No further information has been obtained despite good faith efforts.

• 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: 16329430
• MDR Text Key: 309126612
• Report Number: 3005099803-2023-00450
• 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: K163272
• 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: 03/07/2023

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: 10/21/2023
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0030389492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention