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

Model Number M00553530

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

Patient Problems Abdominal Pain (1685); Discomfort (2330); Multiple Organ Failure (3261)

Event Date 07/31/2023

Event Type  Death  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e1108 captures the reportable event of biliary leakage.Imdrf patient code e2342 captures the reportable event of multiple organ failures related to the reported bile leakage.Imdrf impact code f19 captures the percutaneous drainage procedure performed to address the bile leakage.Imdrf impact code f2303 captures the medical intervention of antibiotics and caspofungin analgesics.Imdrf impact code f02 captures the reportable event of death.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to the bile duct via the duodenal bulb to treat a biliary and duodenal occlusion secondary to pancreatic cancer during a biliary drainage procedure performed on (b)(6) 2023.During the procedure, a guidewire was in place and contrast was used to confirm that the axios stent was successfully placed.It was noted that the guidewire was not used initially because the target was 23mm.However, shortly after the stent was placed, the patient encountered severe abdominal pain and discomfort.A scan was performed which confirmed bile leakage.The axios stent was confirmed to be in the correct location per the scan.Subsequently, the patient had multiple organ failure related to reported major bile leakage.Percutaneous drainage of the abdomen was performed, and the patient was administered antibiotics and caspofungin analgesics.Supportive care was also given.On (b)(6) 2023, the patient passed away.The patient's cause of death is unknown; however, it has been confirmed that the patient had an inoperable pancreatic-head mass causing the biliary and duodenal occlusion.In the physician's assessment, because the leak occurred immediately after the axios placement there is a strong correlation to the procedure and the bile leak.

• 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: 17606051
• MDR Text Key: 321770789
• Report Number: 3005099803-2023-04303
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553530
• Device Catalogue Number: 5353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• 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): Death
• Patient Age: 86 YR
• Patient Sex: Female