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

Model Number	M00517760
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was implanted in the esophagus to treat a 36 x 40 cm malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.On (b)(6) 2024, the patient presented with chest/throat pain and had trouble swallowing.Subsequently, the physician ordered an x-ray, and distal stent migration was confirmed.The stent was then removed using a raptor grasping device and another agile partially covered stent was placed to complete the procedure.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was born in 1964.Block a4: the patient's weight is 111.7 kg; reported here as weight exceeded character limit for designated field.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2203 captures the x-ray imaging done to check the stent.Imdrf impact code f2202 is being used to capture the removal of the migrated stent.Imdrf impact code f2301 is being used to capture the placement of another agile stent.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was implanted in the esophagus to treat a 36 x 40 cm malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.On (b)(6) 2024, the patient presented with chest/throat pain and had trouble swallowing.Subsequently, the physician ordered an x-ray, and stent migration was confirmed.The stent was then removed using a raptor grasping device and another agile partially covered stent was placed to complete the procedure.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was born in 1964.Block a4: the patient's weight is 111.7 kg; reported here as weight exceeded character limit for designated field.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2203 captures the x-ray imaging done to check the stent.Imdrf impact code f2202 is being used to capture the removal of the migrated stent.Imdrf impact code f2301 is being used to capture the placement of another agile stent.Block h12: correction to the initial mdr in block h6 (patient code).

• 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: 20219141
• Report Number: 3005099803-2024-04546
• Device Sequence Number: 17973995
• 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): 10/28/2024

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: 08/21/2024
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Device Lot Number: 0029995893
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/14/2024
• Supplement Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 08/22/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White