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

Model Number M00516750

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/06/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal stent was implanted in the esophagus during a stent placement procedure performed on (b)(6), 2013.According to the complainant, the stent was implanted to treat a benign stricture in the mid esophagus.No issues were noted during stent placement.Reportedly, the patient¿s anatomy was not tortuous.On (b)(6) 2014, the patient was presented in the emergency room and it was noted that the stent migrated which caused obstruction to the pylorus.The stent was removed.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date (b)(4): the device was not returned; therefore, a technical analysis could not be performed.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.Stent migration 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 review of the device history record (dhr) was performed; no anomalies were noted.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: 3687845
• MDR Text Key: 17614139
• Report Number: 3005099803-2014-01359
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091510
• 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: 02/24/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/19/2014
• 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