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

Model Number M00516740

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal stent was used in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a 6cm malignant stricture in the distal esophagus just above the gastro esophageal (ge) junction.Reportedly, the patient¿s anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, when the delivery system was inserted into the patient, the tip bent and was unable to cross the lesion.The stent was unable to be deployed and the physician removed the stent from the patient fully constrained on the delivery catheter.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿fine.¿.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported issue of tip bent.The device was disposed; therefore, a technical analysis could not be performed.The most probable root cause classification of this investigation is operational context.  this is defined as a complaint that is associated with a product that meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.    a review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

• Brand Name: WALLFLEX? ESOPHAGEAL
• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3714902
• MDR Text Key: 20784811
• Report Number: 3005099803-2014-01622
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 0016690090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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