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

Model Number	M00516750
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported to boston scientific corporation on (b)(6 2018 that a wallflex esophageal fully covered stent was implanted to treat a stricture in the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, on (b)(6) 2018, the stent was successfully implanted.On the same day, post procedure, it was noted that the stent had not fully expanded and had migrated.Reportedly, the physician was not comfortable leaving the stent in place.The migrated stent was removed from the patient with an unknown device and a different stent was used 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 fine.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7715439
• Report Number: 3005099803-2018-02344
• Device Sequence Number: 1120681
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 10/25/2019
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 22040918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/24/2018
• 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