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

Model Number M00516740

Device Problem Migration (4003)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 02/17/2023

Event Type  Injury  

Event 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.

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
• 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: 16497856
• MDR Text Key: 310824675
• Report Number: 3005099803-2023-01202
• 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: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 56 KG