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

Model Number	M00516900
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was implanted in the esophagus to treat an esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was successfully deployed.However, there was some resistance upon withdrawal of the delivery system.The delivery system was removed, and it was noted that the tip was missing.The tip was found inside the stent via x-ray.The physician then used a pair of forceps through the scope to push the detached tip into the patient's stomach.In the physician's assessment, the tip would just pass naturally out of the patient.The stent remains implanted, 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 a wallflex esophageal partially covered stent was implanted in the esophagus to treat an esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was successfully deployed.However, there was some resistance upon withdrawal of the delivery system.The delivery system was removed, and it was noted that the tip was missing.The tip was found inside the stent via x-ray.The physician then used a pair of forceps through the scope to push the detached tip into the patient's stomach.In the physician's assessment, the tip would just pass naturally out of the patient.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 has been updated based on the additional information received on may 28, 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments.

• Brand Name: WALLFLEX 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: 19377259
• Report Number: 3005099803-2024-02273
• Device Sequence Number: 12688621
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K073266
• 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): 06/24/2024

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: 12/16/2025
• Device Model Number: M00516900
• Device Catalogue Number: 56453
• Device Lot Number: 0032865976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• 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