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

Model Number	M00516940
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on march 5, 2019 that a wallflex esophageal partially covered stent has been implanted to treat a malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2019.According to the complainant, on an unknown date, the patient came back due to dysphagia.Egd procedure was performed and noticed that the stent had migrated approximately 1cm from the target lesion.Reportedly, the physician tried to remove the stent using a rat tooth forceps but it was not successful.The migrated stent remains implanted and another wallflex esophageal stent was placed to complete the procedure.Reportedly, the stricture had not resolved.There were no patient complications reported as a result of this event and the patient's dysphagia was considered resolved.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8466103
• Report Number: 3005099803-2019-01494
• Device Sequence Number: 1341510
• Product Code: ESW
• UDI-Device Identifier: 08714729765288
• UDI-Public: 08714729765288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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 Expiration Date: 01/15/2021
• Device Model Number: M00516940
• Device Catalogue Number: 1694
• Device Lot Number: 0023196619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR