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

Model Number	M00516750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/16/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf impact code f02 captures the reportable event of death.
Event or Problem Description
Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-06992 for the associated device information.It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during a stent placement procedure performed on (b)(6)2023.On (b)(6) 2023, a second wallflex esophageal fully covered stent was implanted to reinforce the closure of the fistula.On an unknown date, post-stent placement of the second wallflex esophageal stent, the patient passed away.The relationship between the wallflex esophageal stents and the patient's death is unknown.
Additional Manufacturer Narrative
Blocks b2 (date of death), b3, and b5 have been updated with additional information received on january 14, 2024.Block h6: imdrf impact code f02 captures the reportable event of death.
Event or Problem Description
Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report#: 3005099803-2023-06992 and 3005099803-2023-06993 for the associated device information.It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during a stent placement procedure performed on (b)(6) 2023.On (b)(6) 2023, a second wallflex esophageal fully covered stent was implanted to reinforce the closure of the fistula.On an unknown date, post-stent placement of the second wallflex esophageal stent, the patient passed away.The relationship between the wallflex esophageal stents and the patient's death is unknown.Additional information received on january 14, 2024.The patient passed away on (b)(6) 2023.
Additional Manufacturer Narrative
Block h6: imdrf impact code f02 captures the reportable event of death.Block h11: block b5 has been corrected.
Event or Problem Description
Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report#: 3005099803-2023-06992 and 3005099803-2023-06993 for the associated device information.It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during a stent placement procedure performed on (b)(6) 2023.On (b)(6) 2023, a second wallflex esophageal fully covered stent was implanted to reinforce the closure of the fistula.On an unknown date, post-stent placement of the second wallflex esophageal stent, the patient passed away.The relationship between the wallflex esophageal stents and the patient's death is unknown.Additional information received on january 14, 2024.The patient passed away on (b)(6) 2023.Update based on review on january 31, 2024.The first wallflex esophageal stent was partially covered.

• 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: 18451143
• Report Number: 3005099803-2023-06993
• Device Sequence Number: 7566915
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2024
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0031170489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/14/2024; 01/31/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/06/2024; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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: Death
• Patient Sex: Unknown