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

Model Number	M00516740
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on february 17, 2023, that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a malignant extrinsic stricture during an esophageal stent placement procedure performed on (b)(6) 2022.On (b)(6) 2023, post stent placement, the patient began experiencing dysphagia which prompted the physician to check on the status of stent placement.It was noted that the stent had migrated to the stomach.The wallflex esophageal stent remained implanted, and another partially covered stent was implanted.The patient was scheduled to return for the removal of the migrated stent on (b)(6) 2023.There were no reported patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf patient code e1009 captures teh reportable patient complication of dysphagia.Imdrf device code a010402 captures the reportable event of stent migration.Impact code f23 is being used to capture the stent placement procedure and the scheduled stent removal.Impact code of f2301 is being used to capture the additional stent implanted.

• 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: 16497856
• Report Number: 3005099803-2023-01202
• Device Sequence Number: 6536181
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/07/2023

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: 05/31/2023
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 0028469183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 56 KG