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

Model Number	M00517250
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal partially covered stent tts was implanted in the gastroesophageal sphincter to treat a stricture during a therapeutic gastroscopy procedure performed on (b)(6) 2024.The patients anatomy was not tortuous and not dilated prior to stent placement.Ten days post stent placement, the patient experienced severe vomiting that likely caused the stent to migrate proximally.The stent was ultimately coughed out and expelled through the mouth.According to the physician, the stent was too small for the patient's anatomy.There has been no new stent implanted, but the physician plans to implant another stent with a larger diameter size to address the patient's stricture while reducing migration risk.The patient condition was reported to be deteriorating.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1032 captures the reportable event of vomiting.Imdrf impact code f08 captures the reportable event of patient admitted to hospital beyond the standard of care.

• 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: 20245791
• Report Number: 3005099803-2024-04424
• Device Sequence Number: 12583365
• Product Code: ESW
• UDI-Device Identifier: 08714729972952
• UDI-Public: 08714729972952
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 09/18/2024

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: 04/10/2026
• Device Model Number: M00517250
• Device Catalogue Number: 1725
• Device Lot Number: 0033798163
• 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: 08/22/2024
• Initial Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 04/10/2024
• 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: Hospitalization
• Patient Sex: Unknown