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

Model Number	M00517470
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a6: patient's race: caucasian.Block h6: imdrf device code a010402 captures the reportable event of the stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered stent was to be implanted to treat a malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the yellow inner sheath broke, and the stent could not be resheathed.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a6: patient's race: caucasian.Block h6: imdrf device code a010402 captures the reportable event of the stent partially deployed.Block h11: an agile esophageal fully covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the outer and the inner sheath kinked.Functional inspection related to the deployment of the stent was performed by actuating the delivery system (sliding the handle back along the stainless-steel tube), and resistance was felt due to the kinks on the device.No other problems were noted with the device.Product analysis confirmed the reported event of stent partially deployed; however, the reported event of inner shaft/sheath detachment of device or device component was not confirmed.The observed events of inner and outer sheath kinked 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.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered stent was to be implanted to treat a malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the yellow inner sheath broke, and the stent could not be resheathed.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 19632273
• Report Number: 3005099803-2024-03095
• Device Sequence Number: 15605880
• Product Code: ESW
• UDI-Device Identifier: 08714729973096
• UDI-Public: 08714729973096
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: 04/15/2026
• Device Model Number: M00517470
• Device Catalogue Number: 1747
• Device Lot Number: 0033826895
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 66 KG