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

Model Number M00516740

Device Problems Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 338501432
• Report Number: 3005099803-2024-01241
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention