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

Model Number	M00516740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	03/12/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Patient code 1888 captures the reported event of hemorrhage.Patient code 1802 captures the reported event of death.Patient code 3191 captures the additional intervention performed to address the bleeding.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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex esophageal fully covered stent was implanted to treat a focal, friable, post radiation stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on the end of (b)(6) 2019.The patient's anatomy was not dilated prior to stent placement.Reportedly, the patient had esophageal cancer and was undergoing radiation therapy, the mucosa was friable.According to the complainant, on (b)(6) 2020, bleeding at the site of the stent flare was confirmed during an esophagogastroduodenoscopy (egd) procedure.In the physician's assessment, the stent and the friable mucosa of the patient caused or contributed to the bleeding.The patient was transferred to the intensive care unit and undergone a computed tomography arteriogram (ct arteriogram).Reportedly, the patient passed away on (b)(6) 2020 due to bleeding complications.In the physician's assessment, there was somewhat of a relationship between the patient's death and the stent.There was no reported damage or deficiency of the stent.

• 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: 9918402
• Report Number: 3005099803-2020-01408
• Device Sequence Number: 11466689
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/02/2020
• 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: Death; Required Intervention