MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGILE ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00517260
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal partially covered stent was to be implanted in the distal part of the esophagus, across cardias, to treat a malignant stenosis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was able to cross the anatomy.However, the handle was very hard during an attempted stent deployment, and the handle got broken.The stent was removed partially deployed on the delivery system, and a different device was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal partially covered stent was to be implanted in the distal part of the esophagus, across cardias, to treat a malignant stenosis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was able to cross the anatomy.However, the handle was very hard during an attempted stent deployment, and the handle got broken.The stent was removed partially deployed on the delivery system, and a different device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an agile esophageal partially covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the blue outer sheath was buckled, and the inner sheath was kinked.Additionally, the distal handle was returned detached.No other problems were noted with the device.Product analysis confirmed the reported events of stent partially deployed and handle broken.In addition, the blue outer sheath was found buckled, and the inner sheath was kinked.The observed events were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), these events could have then resulted in the stent being unable to fully deploy during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• Brand Name: AGILE ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• 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: 20028662
• Report Number: 3005099803-2024-03913
• Device Sequence Number: 15322433
• Product Code: ESW
• UDI-Device Identifier: 08714729972969
• UDI-Public: 08714729972969
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2025
• Device Model Number: M00517260
• Device Catalogue Number: 1726
• Device Lot Number: 0030856845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown