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

Model Number	M00516750
Medical Device Problem Codes	Positioning Problem (3009); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted 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)(4) 2017 that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a 2 to 3cm tracheoesophageal fistula due to esophageal varices bleeding during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient did not have a concurrent malignant stricture at the site of stent placement.According to the complainant, during the procedure, the stent was deployed but it ended up in the wrong location.Reportedly, the stent did not cover the entire fistula and the physician felt that the stent was shorter than the labeled length.The stent length was measured using a guidewire prior to the procedure.The stent remained implanted and another wallflex esophageal stent was implanted (stent-in-stent) to cover the fistula and 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 good.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6617785
• Report Number: 3005099803-2017-01690
• Device Sequence Number: 19029824
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: (01)08714729778080(17)20171223(10)19409289
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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: 12/23/2017
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 19409289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/07/2017
• 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: 66 YR
• Patient Weight: 70