MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00516720
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal fully covered stent was to be used to treat a tumor in the esophagus during an esophageal stent implantation 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, the stent was able to be deployed.Angiography was performed and noticed the stent had migrated during the first implantation.The stent was removed with forceps and the procedure was completed with another wallflex esophageal fully covered stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8421820
• Report Number: 3005099803-2019-01188
• Device Sequence Number: 11319761
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: 08714729778059
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091510
• 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): 03/14/2019

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: 03/27/2020
• Device Model Number: M00516720
• Device Catalogue Number: 1672
• Device Lot Number: 22711579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/14/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 62