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

Model Number	M00516900
Medical Device Problem Codes	Obstruction of Flow (2423); Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); No Code Available (3191)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the stent 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 august 18, 2020 that a wallflex esophageal partially covered stent was implanted to treat a 5cm malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2020, the patient experienced dysphagia.The physician performed an endoscopic exam and confirmed that the stent migrated and there was tissue ingrowth.The stent remains implanted and the physician was comfortable leaving the stent in place.On (b)(6) 2020, a wallflex fully covered esophageal stent was implanted inside the original stent.Reportedly, the patient will be re-scheduled for esophagectomy to possibly remove the stent.The patient's current condition was reported to be fine.In the physician's assessment the relationship between the dysphagia and the stent was the tissue ingrowth.

• 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: 10511556
• Report Number: 3005099803-2020-03776
• Device Sequence Number: 3074002
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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 Model Number: M00516900
• Device Catalogue Number: 1690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: 60 YR