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); Feeding Problem (1850)
Date of Event	06/17/2024
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 and stomach to treat a malignant ulcerating mass in the distal esophagus during an upper gastrointestinal (gi) endoscopy procedure performed on (b)(6) 2024.On (b)(6) 2024, post stent placement, it was noted that the stent had migrated causing the patient to be unable to eat.The stent was subsequently removed using graspers.The patient's condition was reported to be well.
Additional Manufacturer Narrative
Block a4: patient's weight: 135.6 kg.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1203 captures the reportable event of patient was unable to eat.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was implanted in the esophagus and stomach to treat a malignant ulcerating mass in the distal esophagus during an upper gastrointestinal (gi) endoscopy procedure performed on (b)(6) 2024.On (b)(6) 2024, post stent placement, it was noted that the stent had migrated causing the patient to be unable to eat.The stent was subsequently removed using graspers.The patient's condition was reported to be well.Additional information received on august 06, 2024.It was reported that the patient was unable to swallow solid foods.
Additional Manufacturer Narrative
Block a4: patient's weight: 135.6 kg.Blocks b5 and h6 (patient codes) have been updated based on the additional information received on august 06, 2024.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1203 captures the reportable event of patient was unable to eat.

• 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: 19750951
• Report Number: 3005099803-2024-03402
• Device Sequence Number: 8987721
• 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
• 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): 09/02/2024

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: 04/19/2026
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Device Lot Number: 0033861400
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/02/2024
• Date Device Manufactured: 04/19/2024
• 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