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

Model Number M00553560

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Block e1: (b)(6).Block h6: imdrf device code a150101 captures the reportable event of the stent's first flange failure to expand.Imdrf impact code f2301 captures the additional device required to remove the stent and the additional device to complete the procedure.Imdrf impact code f08 captures prolonged hospitalization of the patient.

Event Description

It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a peri-pancreatic pseudocyst during a pseudocyst drainage procedure performed on (b)(6) 2023.During the procedure, the stent's first flange was not able to completely expand.The axios stent was removed from the patient with forceps fully deployed on the delivery system, and a plastic stent was placed to complete the procedure.There were no patient complications reported as a result of this event; however, the patient was admitted beyond the standard days of hospital care.The patient remains hospitalized but is expected to fully recover.

• 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: 18355443
• MDR Text Key: 330880678
• Report Number: 3005099803-2023-06632
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K233318
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0031724173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 58 KG