MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in common iliac vein.A 18x90/10fr uni plus 75cm wallstent endoprosthesis catheter was selected for use.During deployment, the stent "bulked" and it would not deploy correctly, so the stent was removed.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Age at time of event: 40 years or older.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in common iliac vein.A 18x90/10fr uni plus 75cm wallstent endoprosthesis catheter was selected for use.During deployment, the stent "bulked" and it would not deploy correctly, so the stent was removed.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the shaft buckled when it went inside the patient and stent wouldn't come out.It was not deployed so they just pulled the delivery system out and the delivery system was disposed.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8456305
• Report Number: 2134265-2019-03074
• Device Sequence Number: 2888086
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 06/18/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022270022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1