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

Model Number	M00516730
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Insufficient Information (4580)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the stent was explanted by dr.(b)(6).Block h6: imdrf patient code e2401 captures the reportable event of food impaction.Imdrf impact code f23 is being used to capture the additional intervention of removal of the migrated stent.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 was implanted in the esophagus to treat a 5cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.On (b)(6) 2022, the patient presented to the emergency department with food impaction.Upon checking, it was noted that the stent had completely migrated distally due to the stricture resolution.Subsequently, the stent was removed using graspers and the procedure was completed.
Additional Manufacturer Narrative
Blocks b5 and h6 (patient code) have been updated with additional information received on march 01, 2024.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the stent was explanted by dr.(b)(6).Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f23 is being used to capture the additional intervention of removal of the migrated stent.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 was implanted in the esophagus to treat a 5cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.On (b)(6) 2022, the patient presented to the emergency department with food impaction.Upon checking, it was noted that the stent had completely migrated distally due to the stricture resolution.Subsequently, the stent was removed using graspers and the procedure was completed.**additional information received on march 01, 2024** post-stent placement, the patient's dysphagia initially improved.However, the patient began to develop worsening dysphagia over time.

• 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: 18813013
• Report Number: 3005099803-2024-00797
• Device Sequence Number: 11834593
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: M00516730
• Device Catalogue Number: 1673
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/20/2024
• 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