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

Model Number	M00516930
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been contaminated and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex partially covered esophageal stent was implanted to treat a 2 cm malignant stenosis near the pylorus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, accessing the target location was difficult due to curvatures but the physician was able to deploy the stent.However, it was noted that the stent had not fully expanded and 1 cm of the stenosis was not covered by the stent.During the removal of the delivery system, the stent got caught on the delivery system and the stent was pulled out of position.The physician successfully removed the stent using a biopsy forceps.The physician decided to stop the procedure and plan to perform another stent placement using a different device.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
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7267232
• Report Number: 3005099803-2018-00374
• Device Sequence Number: 1773404
• Product Code: ESW
• UDI-Device Identifier: 08714729765271
• UDI-Public: 08714729765271
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2019
• Device Model Number: M00516930
• Device Lot Number: 21501162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention