MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516740

Device Problem Partial Blockage (1065)

Patient Problems Erosion (1750); Chest Pain (1776); Pneumothorax (2012)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(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 Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered stent was implanted to treat an esophagojejunal anastomotic leak in the esophagus during esophagogastroduonenoscopy (egd) with stent placement procedure performed on (b)(6) 2017.Reportedly, the patient had previously had a total gastrectomy.On (b)(6) 2017, the patient underwent egd with stent placement procedure.The stent was implanted approximately 4-5 cm above the anastomosis.On (b)(6) 2017, the patient experienced chest pain and underwent computed tomography of thorax, abdomen and pelvis (ct tap) and no abdominal collection was identified.The physician noted an extraluminal gas adjacent to the esophagojejunal anastomosis and extended into the pancreatic resection bed with associated strand changes.The physician suspected an anastomotic leak.Additionally, pleural effusion and intraluminal food debris within the stent were noted.On (b)(6) 2017, using ultrasound guidance, a large left pleural effusion was drained.Reportedly, the patient presented with persistent output from external drain.On (b)(6) 2017, during an esophagogram procedure, hydropneumothorax and patient erosion were noted.The erosion was noted to be adjacent to the proximal end of the stent and approximately 4-5 cm proximal to the anastomosis site.Additionally, intraluminal food debris was again noted.Reportedly, the stent remains implanted and the patient¿s condition was reported stable.According to the complainant, in the physician¿s assessment, the stent eroded through the esophagus and caused the hydropneumothorax.The patient refused any surgical intervention or procedure and is under do not resuscitate (dnr) and do not intubate (dni) order.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 6531176
• MDR Text Key: 74005517
• Report Number: 3005099803-2017-01318
• Device Sequence Number: 1
• Product Code: ESW
• 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: 04/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 04/08/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR