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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Septic Shock (2068)

Event Date 07/01/2017

Event Type  Injury  

Event Description

Boston scientific became aware of events involving axios stent and electrocautery enhanced delivery systems through the article, eus-guided choledochoduodenostomy after failed endoscopic retrograde cholangiopancreatography in distal malignant biliary obstruction, by isabel tarrio, et al.Per the article, a retrospective review was done on patients who underwent eus-guided choledochoduodenostomy (eus-cds) with lumen apposing metal stents (lams) between july 2017 and june 2022.A total of 20 patients (65% male) with a median age of 76 years old (range 57-96) underwent lams placement.In 12 patients, the eus-cds was performed in the same endoscopic sessions, immediately after endoscopic retrograde cholangiopancreatography (ercp) failure.The remaining 8 patients were admitted from other hospitals, in which there were no available technical resources and/or experienced endoscopists in eus-guided biliary drainage.Technical success rate was 100% and the clinical success rate was 89.5% according to the study, 4 out of 20 patients presented with cholangitis in the first 30 days after stent placement procedure, and in one case evolving into septic shock.All cases were medically managed with antibiotics.

Manufacturer Narrative

Block a2: patient age is approximated based on the median age being 76.Block b3: the exact date of the event is unknown.Approximated based on the month and year the first procedures were performed.Blocks d4 and h4: the complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Block g2 literature source: tarrio, et al."eus-guided choledochoduodenostomy after failed endoscopic retrograde cholangiopancreatography in distal malignant biliary obstruction" ge port j gastroenterol 2023; doi: 10.1159/000528808 block h6: imdrf patient code 233605 captures the reportable event of septic shock.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf impact code f2303 captures the all cases were medically managed with antibiotics.Imdrf impact code f12 captures the adverse events of cholangitis and septic shock.

• 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: 18155019
• MDR Text Key: 328351981
• Report Number: 3005099803-2023-06196
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR
• Patient Sex: Male