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

Model Number	M00516900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(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 (b)(6) 2019 that a wallflex esophageal partially covered stent had been implanted to treat a malignant stricture in the distal esophagus during a stent placement procedure performed on (b)(6) 2018.After stent placement, the patient's cancer was treated with chemotherapy and radiation.According to the complainant, on (b)(6) 2019, the patient presented with pain, nausea and regurgitation.An esophagogastroduodenoscopy (egd) procedure was performed to examine the stent, and during the procedure, it was observed that the stent was patent and appeared to be in good position.The stent remains implanted and the physician didn't note any issues with the stent.Per the physician, the patient's pain was not related to the stent and the patient didn't have any change in pain related to the stent.In the physician's opinion, the nausea and vomiting were probably due to uncontrolled reflux post stent placement.The patient was treated with zofran, reglan and a high dose of ppi (proton pump inhibitor) to relieve nausea and vomiting as prescribed by the physician.Reportedly, the patient's current condition was reported to be fine but the nausea and vomiting has not yet 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: 8550890
• Report Number: 3005099803-2019-02212
• Device Sequence Number: 2358604
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00516900
• Device Catalogue Number: 1690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/25/2019
• 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: Other
• Patient Age: 54 YR