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

Model Number M00516720

Device Problem Migration (4003)

Patient Problem Discomfort (2330)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown; however, it was reported that the stent was successfully implanted on (b)(6) 2021.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal fully covered stent was implanted to treat a malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not dilated prior to stent placement.Post stent placement, the patient experienced discomfort and imaging was performed.It was noted that the stent migrated.Reportedly, the stent remains implanted and the physician was comfortable leaving the stent implanted.There are no known treatments or interventions for the patient's discomfort.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12752257
• MDR Text Key: 280151728
• Report Number: 3005099803-2021-05616
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: 08714729778059
• Combination Product (y/n): N
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516720
• Device Catalogue Number: 1672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/04/2021
• 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