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

Model Number M00553540

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

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

Event Date 02/06/2024

Event Type  Injury  

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.Imdrf impact code f23 captures the reportable event of additional intervention performed.

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 gallbladder during an endoscopic ultrasound (eus) gallbladder drainage procedure performed on (b)(6) 2024.During the procedure, the first flange of the stent was deployed; however, it did not expand.The physician then intentionally fully deployed the stent to facilitate removal using rat tooth forceps.The puncture site on the stomach was closed using a clip and the patient was sent to interventional radiology (ir) to complete the procedure.There were no patient complications as a result of this event.

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 gallbladder during an endoscopic ultrasound (eus) gallbladder drainage procedure performed on (b)(6) 2024.During the procedure, the first flange of the stent was deployed; however, it did not expand.The physician then intentionally fully deployed the stent to facilitate removal using rat tooth forceps.The puncture site on the stomach was closed using a clip and the patient was sent to interventional radiology (ir) to complete the procedure.There were no patient complications as a result of this event.

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.Imdrf impact code f23 captures the reportable event of additional intervention performed.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.The reported event of stent first flange failure to expand cannot be confirmed as the stent was not returned for evaluation.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, stent positioning issue is noted within the manufacturer's labeling as a known possible adverse event related to the use of the device.Taking all available information into consideration, the investigation concluded that the reported event of stent positioning issue is a known potential complication associated with the use of the device in the manufacturer's labeling.The reported event of stent first flange failure to expand cannot be confirmed as the stent was not returned for evaluation; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: 18825166
• MDR Text Key: 336741869
• Report Number: 3005099803-2024-00800
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0031725826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention