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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816); Pneumonia (2011); Cough (4457); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

The exact date of event was not reported.The manufacturer aware date was used for the estimated date of event.The literature article did not provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Literature source: castillo-larios, r., et al."double stenting for management of a bronchoesophageal fistula".Bronchol intervent pulmonal 2023; doi: 10.1097/lbr.0000000000000843.Imdrf patient code e0717 captures the reportable event of dyspnea.Imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf patient code e0704 captures the reportable event of aspiration.Imdrf patient code e0712 captures the reportable event of cough.Imdrf patient code e2401 captures the reportable event of emphysema and bilioptysis.Imdrf impact code f2301 captures the reported event of the esophageal stent was later removed.

Event Description

Boston scientific corporation became aware of the following event through the article, "double stenting for management of a bronchoesophageal fistula", by castillo-larios, r., et al.According to the literature, a case of a 70-year-old, male, with esophageal adenocarcinoma, was successfully implanted with a wallflex esophageal stent.However, a month later, the patient experienced shortness of breath, worsening cough, right lower lobe pneumonia, and emphysema.A double stenting was performed by implanting an airway stent into the proximal right mainstream.The esophageal stent was later removed due to concerns of the combined radial forces inducing ischemia and potentially worsening the fistulous tract.

• 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: 18647543
• MDR Text Key: 334614982
• Report Number: 3005099803-2024-00226
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male