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

Model Number M00553540

Device Problem Activation Failure (3270)

Patient Problem Perforation (2001)

Event Date 08/26/2023

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 transduodenal to the common bile duct for biliary drainage during an endoscopic ultrasound (eus)-guided choledocodudenostomy procedure performed on (b)(6) 2023.During the procedure, the stent's first flange did not open even after waiting for a few minutes.The device was removed from the patient, but the stent's unexpanded first flange caused a perforation.The stent was removed from the patient partially deployed on the delivery system, and a plastic stent was used to complete the procedure.A computerized tomography (ct) scan was needed to determine the patient's current status.The patient was reported to have been admitted beyond the standard days of hospital care but has been discharged from the hospital.

Manufacturer Narrative

Block e1: additional initial reporter source: dr.(b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent's first flange failure to expand.Imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf impact code f08 is being used to capture the patient's prolonged hospitalization.

• 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: 17769090
• MDR Text Key: 323658114
• Report Number: 3005099803-2023-04947
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0031017067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Race: Asian