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 Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Multiple Organ Failure (3261)

Event Date 03/01/2014

Event Type  Death  

Manufacturer Narrative

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: anderloni, et al."endoscopic ultrasound-guided transmural drainage by cautery tipped lumen-apposing metal stent: exploring the possible indications." annals of gastroenterology 2018; doi https://doi.Org/10.20524/aog.2018.0299.Block h6: imdrf patient code e2342 captures multiple organ failure.Imdrf patient code e211401 captures gallbladder perforation.Imdrf patient code e0506 captures duodenal arterial bleeding.Imdrf impact code f19 captures the surgery due to the gallbladder perforation.Imdrf impact code f02 captures the patient deaths.

Event Description

Boston scientific became aware of the following events involving an axios stent and electrocautery enhanced delivery system through the article, endoscopic ultrasound-guided transmural drainage by cautery tipped lumen-apposing metal stent: exploring the possible indications, by andrea anderloni, et al.Per the article, a retrospective review was done on patients who underwent endoscopic ultrasonography (eus)-guided drainage by lumen apposing metal stent (lams) with cautery system in a tertiary-care academic medical center between (b)(6) 2014 and (b)(6) 2017.A total of 45 patients underwent lams placement.Indications were pancreatic fluid collections (pfc) in 19 patients, acute cholecystitis in 10 patients, and biliary drainage in 16 patients.Eus drainage of pfcs was performed when patients became symptomatic because of size increase or in the event of infection.Eus-guided biliary drainage was performed in patients with unresectable pancreatic or biliary cancer who had undergone a failed attempt at biliary drainage by endoscopic retrograde cholangiopancreatography (ercp).Gallbladder drainage was performed in high-risk surgical patients with a diagnosis of acute cholecystitis, based on the tokyo guidelines as a combination of clinical symptoms, laboratory tests and radiological findings.The procedures were performed on an inpatient basis under deep sedation or under general anesthesia at the discretion of anesthesiologist.Luminal insufflation was performed using carbon dioxide.Technical success was defined as correct lams placement.An adverse event (ae) occurred for one patient with acute cholecystitis.Technical success was achieved in the lams placement case, however, the patient died three days later from multiple organ failure.An ae also occurred for another patient with acute cholecystitis.Technical success was achieved in the lams placement case, however, gallbladder perforation occurred after 17 days which was treated with surgery.The patient died after 63 days from multiple organ failure.An ae also occurred for one patient who underwent biliary decompression by lams.Technical success was achieved in the case.During the follow-up period, the patient died from severe acute duodenal arterial bleeding, 24 days after stent placement.

• 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: 17720729
• MDR Text Key: 323090545
• Report Number: 3005099803-2023-04841
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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: 08/22/2023
• 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): Death