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

Model Number M00516730

Device Problem Device Stenosis (4066)

Patient Problems Abdominal Pain (1685); Pneumonia (2011)

Event Date 09/29/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the esophagus to treat a malignant stenosis during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.The stent was able to be deployed satisfactorily.On (b)(6) , an x-ray was performed due to the patient's ongoing aspiration pneumonia and abdominal pain, and it was noted that there was tissue in growth in the stent.The stent was removed, and another stent was implanted on the same day.The patient was admitted to the hospital on (b)(6) 2022, and discharged on october 13, 2022.In the physician's assessment, the stent unlikely caused the pneumonia.However, since the patient has esophageal cancer and some other ongoing medical complications, it is unknown if the stent caused or contributed to the patient's complications.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0106 captures the reportable event of stent overgrowth.Imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent and implant another stent.

• 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: 18810916
• MDR Text Key: 336615764
• Report Number: 3005099803-2024-00767
• 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