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

Model Number M00516730

Device Problem Migration (4003)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

A2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.D4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.H6: imdrf device code a010402 captures the reportable event of a stent's migration.Imdrf patient code e1009 captures the patient's dysphagia.Imdrf impact code f23 captures the unexpected medical intervention to remove the stent.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat a malignant obstructive esophageal tumor during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2022.On (b)(6) 2022, the patient was scheduled for cryotherapy for an esophageal tumor, and it was noticed during the procedure that the stent had completely migrated to the distal part of the anatomy.On the same day, the stent was adjusted and re-sutured in place using the apollo overstitch.On (b)(6) 2022, the stent was removed from the patient using graspers.The patient was reported to have experienced dysphagia.

• 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: 18810778
• MDR Text Key: 336589424
• Report Number: 3005099803-2024-00728
• Device Sequence Number: 1
• Product Code: ESW
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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