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

Model Number M00516740

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 03/12/2020

Event Type  Death  

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 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
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9918402
• MDR Text Key: 186229707
• Report Number: 3005099803-2020-01408
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/02/2020
• 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
• Patient Outcome(s): Death; Required Intervention