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

Device Problems Human-Device Interface Problem (2949); Activation Failure (3270); Device Stenosis (4066)

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067)

Event Date 10/01/2017

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "performance characteristics of a lumen-apposing metal stent for pancreatic fluid collections: a prospective cohort study." according to the literature, an axios stent and electrocautery enhanced delivery system was implanted to treat a pancreatic fluid collection during an endoscopic ultrasound-guided transmural drainage procedure performed on an unknown date.It was reported that the patient experienced fever and leukocytosis two days post stent placement.The patient underwent esophagogastroduodenoscopy (egd) procedure, and it was noted that the stent did not fully expand.The patient was treated with antibiotics and underwent a computed tomography (ct) scan.Stent ingrowth was also noted during the stent removal procedure.The stent was successfully removed using a rat tooth forceps.Another patient experienced abdominal sepsis and underwent a surgery.

Manufacturer Narrative

Exact date unknown, event occurred between october 2017 and september 2019.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Literature source: gurpal s, et al.Performance characteristics of a lumen-apposing metal stent for pancreatic fluid collections: a prospective cohort study.Journal of the canadian association of gastroenterology 2021: 4(4) p.3158-164.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a0106 captures the reportable event of stent ingrowth.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e230101 captures the reportable event of fever.Imdrf patient code e0311 captures the reportable event of leukocytosis.Imdrf patient code e0306 captures the reportable event of abdominal sepsis.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f23 captures the reportable event of additional interventions performed to address the patient complications.Imdrf impact code f19 captures the reportable event of surgery performed.

Manufacturer Narrative

Block b3: exact date unknown, event occurred between october 2017 and september 2019.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block g2: literature source: gurpal s, et al.Performance characteristics of a lumen-apposing metal stent for pancreatic fluid collections: a prospective cohort study.Journal of the canadian association of gastroenterology 2021: 4(4) p.3158-164.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a22 captures the reportable event of stent overgrowth.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e230101 captures the reportable event of fever.Imdrf patient code e0311 captures the reportable event of leukocytosis.Imdrf patient code e0306 captures the reportable event of abdominal sepsis.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f23 captures the reportable event of additional interventions performed to address the patient complications.Imdrf impact code f19 captures the reportable event of surgery performed.Block h11: blocks h6 (device codes) and h10 have been corrected.

Event Description

Boston scientific corporation became aware of the following event from referenced literature article "performance characteristics of a lumen-apposing metal stent for pancreatic fluid collections: a prospective cohort study." according to the literature, an axios stent and electrocautery enhanced delivery system was implanted to treat a pancreatic fluid collection during an endoscopic ultrasound-guided transmural drainage procedure performed on an unknown date.It was reported that the patient experienced fever and leukocytosis two days post stent placement.The patient underwent esophagogastroduodenoscopy (egd) procedure, and it was noted that the stent did not fully expand.The patient was treated with antibiotics and underwent a computed tomography (ct) scan.Stent overgrowth was also noted during the stent removal procedure.The stent was successfully removed using a rat tooth forceps.Another patient experienced abdominal sepsis and underwent a surgery.

• 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: 16350541
• MDR Text Key: 309261061
• Report Number: 3005099803-2023-00418
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention