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

Model Number	26280
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the inferior vena cava.A 24x70/11fr uni plus 75cm wallstent endoprosthesis was deployed to treat the lesion.However, the deployed stent migrated approximately 1cm distal.A non-bsc balloon catheter was then inflated into the stent and used to drag the stent down into the appropriate position and the procedure was completed.No further patient complications were reported.
Additional Manufacturer Narrative
B3: date of event updated.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the inferior vena cava.A 24x70/11fr uni plus 75cm wallstent endoprosthesis was deployed to treat the lesion.However, the deployed stent migrated approximately 1cm distal.A non-bsc balloon catheter was then inflated into the stent and used to drag the stent down into the appropriate position and the procedure was completed.No further patient complications were reported.It was further reported that there was a 70% stenosis in the lesion.

• 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: 8935949
• Report Number: 2134265-2019-10302
• Device Sequence Number: 2000206
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/05/2019

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: 02/16/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021754625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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