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

Model Number M00516210

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f2301 is being used to capture the removal of the stent.

Event Description

Note: this report pertains to one of three devices used in the same patient.Refer to manufacturer reports # 3005099803-2023-06204, 3005099803-2024-00099 for the associated device information.It was reported to boston scientific corporation that a wallflex fully covered esophageal stent was implanted on (b)(6) 2023, in the middle esophagus to address a persistent dysphagia after two previously implanted agile esophageal stents performed (b)(6) 2023 respectively.The patient's anatomy was tortuous.On (b)(6) 2023, the patient was implanted with an agile esophageal partially covered stent (the subject of mfr.Report # 3005099803-2024-00099) to treat a malignant stricture; however, on (b)(6) 2023, the patient presented with dysphagia prompting the physician to check the stent.Stent ingrowth was observed, and the stent was repositioned.On (b)(6) 2023, the patient again experienced dysphagia, thus, a second agile esophageal stent (the subject of mfr.Report # 3005099803-2023-06204) was implanted.Subsequently, on (b)(6) 2023, the patient again presented with dysphagia which physician then observed a stent ingrowth.A wallflex esophageal stent (the subject of this report) was then implanted to restore patency.On (b)(6) 2024, the patient presented with dysphagia for the fourth time, thus, consequently, both the second agile and the wallflex esophageal stents were removed.A non-boston scientific stent was then placed stent-in-stent on the uncovered portion of the first agile esophageal stent.

Manufacturer Narrative

Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f2301 is being used to capture the removal of the stent.Block h11: correction to the initial mdr in block h6 (impact codes).

Event Description

Note: this report pertains to one of three devices used in the same patient.Refer to manufacturer reports # 3005099803-2023-06204, 3005099803-2024-00099, and 3005099803-2024-01133 for the associated device information.It was reported to boston scientific corporation that a wallflex fully covered esophageal stent was implanted on (b)(6) 2023, in the middle esophagus to address a persistent dysphagia after two previously implanted agile esophageal stents performed (b)(6)2023 and (b)(6) 2023 respectively.The patient's anatomy was tortuous.On (b)(6) 2023, the patient was implanted with an agile esophageal partially covered stent (the subject of mfr.Report # 3005099803-2024-00099) to treat a malignant stricture; however, on (b)(6) 2023, the patient presented with dysphagia prompting the physician to check the stent.Stent ingrowth was observed, and the stent was repositioned.On (b)(6) 2023, the patient again experienced dysphagia, thus, a second agile esophageal stent (the subject of mfr.Report # 3005099803-2023-06204) was implanted.Subsequently, on (b)(6) 2023, the patient again presented with dysphagia which physician then observed a stent ingrowth.A wallflex esophageal stent (the subject of this report) was then implanted to restore patency.On (b)(6) 2024, the patient presented with dysphagia for the fourth time, thus, consequently, both the second agile and the wallflex esophageal stents were removed.A non-boston scientific stent was then placed stent-in-stent on the uncovered portion of the first agile esophageal 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: 18935496
• MDR Text Key: 338068653
• Report Number: 3005099803-2024-01133
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K091510
• 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
• Report Date: 04/29/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: M00516210
• Device Catalogue Number: 1621
• Device Lot Number: 0032224095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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