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

Model Number M00553660

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastic to the jejunum to treat a gastric outlet obstruction (goo) during an esophagogastroduodenoscopy (egd) / endoscopic ultrasound (eus) with gastrojejunostomy procedure performed on (b)(6) 2024.During the procedure, the stent was deployed; however, it was not completely in the colon and later moved out of its position and into the peritoneum.The stent was removed with grasping forceps and another axios stent was implanted right next to the initial puncture site.The patient had a collection outside the stomach due to the leak at the initial puncture site and no intervention was performed to close the puncture site at the colon.On (b)(6) 2024, the collection was irrigated, and the gastric hole was closed with endosuturing.The patient is reported to be doing well.Note: it was reported that the axios stent was to be implanted to treat a gastric outlet obstruction (goo) during an endoscopic ultrasound (eus) with gastrojejunostomy procedure.However, per the axios stent and electrocautery-enhanced delivery system instructions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall.The axios stent is not indicated to be implanted to treat a gastric outlet obstruction (goo).

Manufacturer Narrative

Block e1: the reported healthcare facility is: (b)(6).Block h6: imdrf patient code e2114 captures the reportable patient complication of colon perforation.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f23 captures the additional procedure of collection irrigation and endo-suturing.

• 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: 18879891
• MDR Text Key: 337405218
• Report Number: 3005099803-2024-00951
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0032632258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• 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