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

Model Number	M00516740
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code 10401 captures the reportable event of stent suture break.Imdrf device code a010402 captures the reportable event of stent migration.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent rmv was implanted in the esophagus to treat an esophageal cancer during a stent placement procedure performed on an unknown date.During a stent removal procedure, the stent was attempted to be removed, however, the stent suture loop fell off.The stent was then noted to have migrated to the stomach.The migrated stent was removed using a snare 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 fully covered stent rmv was implanted in the esophagus to treat an esophageal cancer during a stent placement procedure performed on an unknown date.During a stent removal procedure, the stent was attempted to be removed, however, the stent suture loop fell off.The stent was then noted to have migrated to the stomach.The migrated stent was removed using a snare and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block d4 (model number, catalog number, and unique identifier (udi) #) have been updated based on the additional information received on april 05, 2024.Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code 10401 captures the reportable event of stent suture break.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2202 captures the reportable event of the patient needed a stent removal.Block h6 (impact code) was updated following a medical review which identified that impact code of endoscopic procedure should be added.

• 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: 18969677
• Report Number: 3005099803-2024-01241
• Device Sequence Number: 6694068
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Model Number: M00516740
• Device Catalogue Number: 1674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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