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	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: not under 18 or 25 years old.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the common iliac vein.A 20x80/10fr 75cm wallstent endoprosthesis was advanced to treat the lesion.The stent was placed and it appeared to be positioned correctly.The physician then post-dilated the sent with an unspecified 20mm balloon catheter at the proximal end of the stent.However, when the balloon was deflated after post-dilation, the stent moved proximally for an unknown reason.It ended up being in a location that was a little bit higher than they wanted it.Additional wallstent devices were implanted to cover the compressed areas.Even without the issue with the migration additional stents would have likely been needed anyways.The procedure was completed.No patient complications were reported and the patient's status was fine.

• 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: 8095374
• Report Number: 2134265-2018-63061
• Device Sequence Number: 2791769
• Product Code: JCT
• UDI-Device Identifier: 08714729204114
• UDI-Public: 08714729204114
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 10/02/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022740442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/21/2018
• 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