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

Model Number	M00516700
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf patient code e2230 captures the reportable event of pan.Imdrf impact code f2301 captures the reportable event of the stent was removed using graspers.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent implanted in the esophagus to treat a stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2023.During the procedure, the stent was successfully deployed.On (b)(6) 2023, the patient was unable to eat and presented to the emergency room.Upper gi endoscopy was performed, and it was noted that the stent migrated into the stomach.The migration was due to stricture resolution; however, the patient was still experiencing pain and dysphagia.Subsequently, the stent was removed using graspers and the procedure was completed.

• 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: 19130280
• Report Number: 3005099803-2024-01779
• Device Sequence Number: 6853468
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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: 08/17/2024
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0031071013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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