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

Model Number M00553550

Device Problems Use of Device Problem (1670); Activation Failure (3270)

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

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.

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 pseudocyst during an endosonography procedure performed on (b)(6) 2024.During the procedure, the first flange of the stent was deployed, but it didn't expand.The physician then proceeded to deploy the second flange.The second flange expanded, but since the first flange still did not expand, the physician decided to remove the stent using grasping forceps.Another axios stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and good.Note: it was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system instructions for use state "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

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 pseudocyst during an endosonography procedure performed on (b)(6) 2024.During the procedure, the first flange of the stent was deployed, but it didn't expand.The physician then proceeded to deploy the second flange.The second flange expanded, but since the first flange still did not expand, the physician decided to remove the stent using grasping forceps.Another axios stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and good.Note: it was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system instructions for use state "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h10: an axios electrocautery enhanced delivery system was received for analysis; the stent was not returned.The delivery system was inspected, and no damages were noted.A destructive inspection was necessary to identify torsion of the delivery system and the outer sheath was not found twisted.The reported event of stent first flange failure to expand cannot be confirmed as the stent was not returned.Based on the available information, there is not enough evidence to determine the most probable cause of the reported event of stent first flange failure to expand.The investigation findings did not lead to a clear conclusion about the cause of the reported event; without analysis of the stent, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.Therefore, the most probable cause was unable to be established.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the handle was rotated as the device was luer locked to the scope.The ifu states "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope.".

• 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: 18925546
• MDR Text Key: 337922408
• Report Number: 3005099803-2024-01024
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0032283610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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): Required Intervention