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

Model Number	M00516730
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pneumonia (2011)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 18810916
• Report Number: 3005099803-2024-00767
• Device Sequence Number: 8239871
• 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
• Report Date (Section B): 02/29/2024

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): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/29/2024
• 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