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

Model Number UNK477

Device Problem Partial Blockage (1065)

Patient Problems Erosion (1750); Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Although the exact patient age was not provided, the patient was reported to be over 18 years of age.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However the complainant noted that the device was used prior to the expiration date.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 that a wallflex(tm) esophageal stent was implanted to treat a malignant stricture in the distal esophagus during a procedure performed on an unknown date.Reportedly, the patient had been undergoing radiation treatment.According to the complainant, the patient had presented at the emergency room with an upper gi bleed a couple of months after the wallflex(tm) esophageal stent had been placed (on an unknown date).The physician attempted to stop the bleed but was unsuccessful.During an upper endoscopy procedure on an unknown date, the physician confirmed that the patient had a fistula.The proximal flare of the stent was noted to have become occluded with tissue ingrowth that extended into the aorta.The proximal flare eroded through the weakened esophageal wall into the patient's aorta.In the physician's assessment, the bleeding was caused by blood from the aorta leaking into the esophagus through the fistula.The wallflex(tm) esophageal stent was not removed from the patient.The patient passed away on an unknown date.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 5621360
• MDR Text Key: 44114886
• Report Number: 3005099803-2016-01163
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• 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