MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number UNK476

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

Patient Problems Aspiration/Inhalation (1725); Cardiac Arrest (1762); Death (1802)

Event Date 09/12/2016

Event Type  Death  

Manufacturer Narrative

The mean age of patients included in the study was 69.7 years (range 63-81 years).The study included 100 patients: 43 males and 57 females.The corresponding author provided the lot number and upn for the device implanted within the patient who suffered aspiration only and died.The lot number is 12332458 and the upn is m00565020.The manufacture date for this device is 01/21/2009 and the expiration date is 01/20/2011.The specific upn and lot number of the other stent was not reported; therefore, the manufacture date and expiration date are unknown.(b)(4).The devices have not been received for analysis; therefore, a failure analysis of the complaint devices could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Boston scientific corporation became aware of multiple events through the article ¿the location of obstruction predicts stent occlusion in malignant gastric outlet obstruction¿ written by douglas grunwald, et al.According to the literature, the aim of the study was to determine whether the location of the malignant obstruction and stent angulation are associated with stent occlusion requiring reintervention.The study took place between 2006 and 2015, and included 100 patients.The etiology of patients¿ obstructions included gastric cancer (n = 15), duodenal cancer (n = 8), pancreatic cancer (n = 44), biliary cancer (n = 14), and other cancer types (n = 19).All patients were treated with wallflex enteral duodenal stents.Two patients experienced complications that led to periprocedural death.The article states that these complications were directly related to the stent placement and were not due to other circumstances, like pre-stent dilation.According to the corresponding author of the article, one of these patients underwent stent placement in the duodenum on (b)(6) 2007.This patient suffered from aspiration and cardiac death and subsequently died.The second patient underwent stent placement on (b)(6) 2009.This patient also experienced aspiration and subsequently died.The article and corresponding author did not provide any further information regarding these patients.If any additional information is received, a supplemental report will be filed.

• Brand Name: WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6413030
• MDR Text Key: 70240323
• Report Number: 3005099803-2017-00746
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• 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: 02/20/2017

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: UNK476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/17/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death