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

Model Number M00516920

Device Problems Partial Blockage (1065); Material Deformation (2976)

Patient Problems Vomiting (2144); Ulcer (2274)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) stent blocked/occluded.(b)(4) stent damaged.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a wallflex partially covered esophageal stent was implanted to treat a stricture in the distal oesophagus during a procedure performed on (b)(6) 2013.According to the complainant, the patient had been lost to follow up post initial stent placement procedure.The patient presented with hematemesis and was found to have a gastric ulcer on an unknown date in (b)(6) 2015.The hematemesis and gastric ulcer were treated during a laparoscopic procedure and oversew.The physician noted overgrowth at the top of the stent during a gastroscopy procedure and on (b)(6) 2015 a wallflex fully covered esophageal stent was implanted within the indwelling stent in order to create pressure necrosis.During a repeat gastroscopy procedure on (b)(6) 2015, the wallflex fully covered esophageal stent was removed from the patient without issue.However the physician noted that both the proximal and distal ends of the wallflex partially covered esophageal stent appeared to have broken down with sharp edges.The physician was unable to safely remove the wallflex partially covered esophageal stent endoscopically.The physician confirmed that the hematemesis and gastric ulcer had resolved.The wallflex partially covered esophageal stent was successfully removed on an unknown date using a combination of open surgery through the stomach and endoscopic techniques.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: 5221533
• MDR Text Key: 31073044
• Report Number: 3005099803-2015-03212
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K073266
• 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
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2014
• Device Model Number: M00516920
• Device Lot Number: 15203983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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