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

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

Patient Problems Fistula (1862); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the following event through the article, "spinal cord compression related to an esophageal self-expandable metal stent", by nehme, f., et al.According to the literature, a case of a 85-year-old, female, with non-small cell lung cancer, was successfully implanted with a wallflex fully covered metal stent over the fistula site.Six weeks post stent placement, a follow up esophagram was performed, and results revealed a persistent leak with pooling of contrast material along the side of the stent to the fistula site.The tracheoesophageal fistula was confirmed on upper endoscopy.Therefore, the wallflex stent was exchanged and another esophageal stent was then placed.

Manufacturer Narrative

The exact date of event was not reported.The manufacturer awareness date is 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: nehme, f., et al."spinal cord compression related to an esophageal self-expandable metal stent".Gastrointestinal endoscopy; doi: https://doi.Org/10.1016/j.Gie.2022.10.013.Imdrf patient code e2401 captures the reportable event of persistent leak.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf impact code f2202 captures the reportable event of a follow up esophagram was performed.Imdrf impact code f2301 captures the reportable event of another esophageal stent was implanted.

Manufacturer Narrative

Block b3: the exact date of event was not reported.The manufacturer awareness date is used for the estimated date of event.Block b5 has been updated based on the additional information received on january 30, 2024.Block d4, h4: the literature article did not provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: nehme, f., et al."spinal cord compression related to an esophageal self-expandable metal stent".Gastrointestinal endoscopy; doi: https://doi.Org/10.1016/j.Gie.2022.10.013.Block h6: imdrf patient code e2401 captures the reportable event of persistent leak.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf impact code f2202 captures the reportable event of a follow up esophagram was performed.Imdrf impact code f2301 captures the reportable event of another esophageal stent was implanted.

Event Description

Boston scientific corporation became aware of the following event through the article, "spinal cord compression related to an esophageal self-expandable metal stent", by nehme, f., et al.According to the literature, a case of a 85-year-old, female, with non-small cell lung cancer, was successfully implanted with a wallflex fully covered metal stent over the fistula site.Six weeks post stent placement, a follow up esophagram was performed, and results revealed a persistent leak with pooling of contrast material along the side of the stent to the fistula site.The tracheoesophageal fistula was confirmed on upper endoscopy, and another esophageal stent was then placed.***additional information received on january 30, 2024*** the reported adverse event (spinal cord compression) occurred after the wallflex stent had been removed and replaced with a different stent.The patient had a fistula prior to stent placement, and did not improve following stent placement.

• 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: 18612904
• MDR Text Key: 334148358
• Report Number: 3005099803-2024-00232
• 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,Followup
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/23/2024
• 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: 85 YR
• Patient Sex: Female