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

Model Number	M00516720
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(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) 2019 that a wallflex esophageal fully covered stent was implanted to treat a fistula in esophago-jejunal anastomosis in the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous.According to the complainant, on (b)(6) 2019, the fistula had resolved and during a planned stent removal procedure, the stent retention suture broke while trying to remove the stent out from the patient.The stent was successfully removed by grasping it from the stent wall.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.According to the complainant, the wallflex esophageal fully covered stent was placed for fistula in an esophago-jejunal anastomosis.However, per wallflex esophageal fully covered stent system directions for use, the stent is contraindicated for placement in an esophago-jejunostomy (following gastrectomy), as peristalsis and altered anatomy may displace stent.

• 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: 8562554
• Report Number: 3005099803-2019-02231
• Device Sequence Number: 1852230
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: 08714729778059
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2018
• Device Model Number: M00516720
• Device Catalogue Number: 1672
• Device Lot Number: 0020689054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1