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 06/26/2023

Event Type  Injury  

Manufacturer Narrative

A2: patient's exact age is unknown.However, it was reported that the patient was under 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.E1: the stent was repositioned by dr.(b)(6) with assistance from dr.Andrew hsu who was present in both cases (stent placement and repositioning).H6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f23 is being used to capture the additional intervention of repositioning the migrated stent.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 was implanted in the esophagus to treat an 8cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement procedure.On (b)(6) 2023, post-stent placement, the patient presented with dysphagia.Upon checking, it was noted that the stent had partially migrated proximally.The stent was repositioned using alligator forceps and the procedure was completed.

• 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: 18810913
• MDR Text Key: 336590272
• Report Number: 3005099803-2024-00778
• 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