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

Model Number M00516950

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2023

Event Type  Death  

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 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.

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 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.

Manufacturer Narrative

Block h6: imdrf impact code f02 captures the reportable event of death.Block h11: block b5 has been corrected.

Event 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
• 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: 18447569
• MDR Text Key: 332151754
• Report Number: 3005099803-2023-06992
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Model Number: M00516950
• Device Catalogue Number: 1695
• Device Lot Number: 0029871456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/14/2024; 01/31/2024
• Supplement Dates FDA Received: 02/06/2024; 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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): Death