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

Model Number	M00514240
Medical Device Problem Codes	Misassembled (1398); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the physician used rescue forceps to adjust the stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered proximal release stent was implanted in the esophagus to treat a malignant tumor during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the radiopaque markers did not indicate the exact place where the coverage of the stent was after full deployment.The stent was 2cm below the markers and was not covering the stenosis.The physician then used rescue forceps to adjust the stent, and the procedure was completed.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered proximal release stent was implanted in the esophagus to treat a malignant tumor during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the radiopaque markers did not indicate the exact place where the coverage of the stent was after full deployment.The stent was 2cm below the markers and was not covering the stenosis.The physician then used rescue forceps to adjust the stent, and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on january 7, 2025.It was reported that the patient's anatomy was stenotic but was not tortuous and the procedure performed was esophagogastroduodenoscopy (egd).
Additional Manufacturer Narrative
Block b5 was updated based on the additional information received on january 7, 2025.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the physician used rescue forceps to adjust the stent.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21105735
• Report Number: 3005099803-2024-06724
• Device Sequence Number: 8782406
• Product Code: ESW
• UDI-Device Identifier: 08714729716105
• UDI-Public: 08714729716105
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 01/29/2025

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: 05/20/2026
• Device Model Number: M00514240
• Device Catalogue Number: M00514240
• Device Lot Number: 0034065569
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/29/2025
• Date Device Manufactured: 05/20/2024
• 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 Sex: Unknown