MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ultraflex? Esophageal NG; prosthesis, esophageal

Model Number	M00513730
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng covered distal release stent was implanted in the esophagus to treat a 6 cm malignant esophageal stenosis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2026.The patient's anatomy was tortuous and was dilated prior to stent placement.On (b)(6) 2026, post stent placement, it was noted under imaging examination that the stent had migrated.The stent was removed using biopsy forceps, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of the migrated stent was removed.Imdrf impact code f2203 captures the reportable event of the imaging examination.

• Brand Name: Ultraflex? Esophageal NG
• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50805009
• Report Number: 3005099803-2026-03835
• Device Sequence Number: 8597422
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)270219(10)35888650
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0035888650
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 02/19/2025
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 132 LB