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

Model Number UNK477

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the upn and 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.Reported event of stent migration.The complainant indicated that the device was disposed 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) 2015 that a wallflex¿ esophageal fully covered stent was used in the distal esophagus during a gastroscopy procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 3-4 cm post radiation stricture which is approximately 3-4 cm proximal to the gastro-oesophageal junction (goj).Reportedly the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure the physician deployed the wallflex¿ esophageal stent in the desired location without issue.Approximately 4 hours after stent placement, the patient had a coughing fit and coughed the stent up and out of from the mouth.The physician was undecided whether to place another stent at the stricture.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 stable.

Manufacturer Narrative

A fully deployed wallflex¿ esophageal fully covered stent was returned for analysis.Visual and microscopic analysis found that there were no issues noted on the profile of the stent that could have contributed to the complaint incident.During product analysis, the proximal flare diameter, the distal flare diameter, and the overall length of the stent were measured which were within specifications.No other issues were identified during the product analysis."stent migration" is a known complication associated with the use of this device, and is listed in the directions for use (dfu) / product label.Therefore, the root cause of this complaint is anticipated procedural complication.

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that a wallflex¿ esophageal fully covered stent was used in the distal esophagus during a gastroscopy procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 3-4 cm post radiation stricture which is approximately 3-4 cm proximal to the gastro-oesophageal junction (goj).Reportedly the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure the physician deployed the wallflex¿ esophageal stent in the desired location without issue.Approximately 4 hours after stent placement, the patient had a coughing fit and coughed the stent up and out of from the mouth.The physician was undecided whether to place another stent at the stricture.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 stable.

• 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: 5219952
• MDR Text Key: 30995496
• Report Number: 3005099803-2015-03099
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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