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

Model Number	M00517760
Medical Device Problem Codes	Migration (4003); Device Stenosis (4066)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on july 23, 2024.Block a2: the patient's year of birth is 1965.Block a4: the patient's weight is 129.3 kg.Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0106 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered otw stent was implanted in the esophagus to treat a malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6), 2024.On (b)(6) 2024, the patient presented to the emergency department (ed) with dysphagia.The stent was checked, and a complete proximal stent migration was noted.Additionally, stent occlusion occurred due to food impaction.Subsequently, the stent was removed using a rat-tooth forceps and another stent was placed to complete the procedure.Additional information received on july 23, 2024.The stent was replaced with a wallflex esophageal stent.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered otw stent was implanted in the esophagus to treat a malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.On (b)(6) 2024, the patient presented to the emergency department (ed) with dysphagia.The stent was checked, and a complete proximal stent migration was noted.Additionally, stent occlusion occurred due to food impaction.Subsequently, the stent was removed using a rat-tooth forceps and another stent was placed to complete the procedure.
Additional Manufacturer Narrative
Block a2: the patient's year of birth is 1965.Block a4: the patient's weight is 129.3 kg.Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0106 captures the reportable event of stent obstruction within device.

• Brand Name: AGILE ESOPHAGEAL OTW
• 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: 19831848
• Report Number: 3005099803-2024-03517
• Device Sequence Number: 7513710
• Product Code: ESW
• UDI-Device Identifier: 00191506006631
• UDI-Public: 00191506006631
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K211960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2026
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Device Lot Number: 0033478456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 02/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White