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); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 03/01/2024

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 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 did not expand.The physician then proceeded to deploy the second flange.The physician waited for a few minutes; however, the first flange still did not expand.The stent was removed with forceps and 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 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.Imdrf device code a1502 captures the reportable event of stent positioning issue.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Block h10: an axios stent and electrocautery enhanced delivery system were received for analysis.The stent was received fully deployed and expanded.A destructive inspection was necessary to identify torsion of the delivery system and the outer sheath was not found twisted.A dimensional inspection was performed, and the stent was measured to be within specification.No other problems were noted with the stent and delivery system.The reported event of stent failure to expand cannot be confirmed as the stent was received fully deployed and expanded.The reported event of stent positioning issue cannot be confirmed as this event occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Based on the available information, there is not enough information to confirm the reported events of stent failure to expand and stent positioning issue; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.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." additionally, stent positioning issue is noted within the manufacturer's labeling as a known possible adverse event related to the use of the device.

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 physician waited for a few minutes; however, the first flange still did not expand.The stent was removed with forceps and 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 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.".

• 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: 18927370
• MDR Text Key: 337943990
• Report Number: 3005099803-2024-01090
• 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: 0032751580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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): Required Intervention