MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00514200

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

Patient Problems Inflammation (1932); Perforation (2001)

Event Date 01/19/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was used in the esophagus during an esophageal stent deployment procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat an anastomotic stricture in the esophagus caused by surgery to remove peritoneal dissemination caused by stomach cancer.Reportedly, the patient anatomy location was noted to be tortuous.During the procedure, the physician noted resistance upon advancing the stent to the lesion.When a contrast radiography was performed, it was noted that free air had occurred.A computed tomography confirmed that the patient had a perforation in the tumor near the anastomotic site.The patient developed peritonitis due to the perforation.The physician believed that the perforation is covered by the stent, which is preventing worsening peritonitis.According to the physician¿s assessment, the delivery system of the stent may have caused the perforation.The stent remains in place and the physician does not plan to perform additional intervention or surgery due to the patient condition.

Manufacturer Narrative

The complainant was unable to provide the lot number; therefore, the lot expiration and device manufacture dates are unknown.Investigation results: a visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.From the information available this device was used per the directions for use (dfu) / product label.Perforation is listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4491363
• MDR Text Key: 5344248
• Report Number: 3005099803-2015-00259
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

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: M00514200
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 02/06/2015
• 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): Other