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

Model Number	26280
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.A 16x60/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment; however, the stent migrated post deployment.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent migration occurred.A 16x60/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment; however, the stent migrated post deployment.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the left external iliac vein with 60% stenosis.The vessel diameter measured 16mm in the common iliac vein and ranged down to 13mm in the external vein segment.When the stent was implanted, it foreshortened distally and was not able to completely cover the stenosis in the distal external iliac vein.

• 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: 10009676
• Report Number: 2134265-2020-05771
• Device Sequence Number: 16868140
• Product Code: MAF
• UDI-Device Identifier: 08714729204046
• UDI-Public: 08714729204046
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 12/01/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024853304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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