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

Model Number M00516700

Device Problems Partial Blockage (1065); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6), 2015 that a wallflex esophageal covered stent was implanted in the esophagus during an esophageal metal stenting procedure performed on (b)(6), 2015.According to the complainant, the stent was placed to cover a 3-4cm tracheoesophageal fistula in the upper esophagus due to cancer in the lung and esophagus.Reportedly, the patient's anatomy was noted to be tortuous due to esophageal compression from an extrinsic tumor.The stent was successfully implanted with no issues to cover the fistula.On (b)(6), 2015, the patient experienced discomfort.In the physician¿s assessment the discomfort was due to food or fluid leakage from the esophagus to the trachea.The physician injected contrast media under fluoroscopy to check the patency of the wallflex stent and noted that the stent was not preventing leakage even though the stent cover was not damaged.The physician attempted to remove the implanted stent; however, it could not be removed due to epithelialization.A second wallflex esophageal covered stent was implanted within the first stent to complete the procedure.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

(b)(4).The complainant indicated that the device remains implanted and will not be returned for investigation.Therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4870658
• MDR Text Key: 5866645
• Report Number: 3005099803-2015-01770
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2016
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 17307130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64