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 Code Available (3191)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred and required additional intervention.On (b)(6) 2020, the more than 75% stenosed target lesion, measuring 15mm in healthy vessel, was located in the right subclavian vein and noted via ivus.During the procedure, a 16mm x 60mm x 75cm wallstent endoprosthesis stent was deployed.The stent was pre and post dilated with charger balloon dilatation catheters 8mm x 40mm and 10 mm x 40mm.The physician was pleased with the results and the patient outcome was optimal.On (b)(6) 2020, it was noted that the wallstent had migrated to the superior vena cava, past the initial stenosis and placement by at least 2-3 cm.A 16mm x 60mm vici venous stent was placed at the lesion.Post dilatation was completed with a balloon catheter.There were no patient complications nor injuries reported and the patient was stable and doing well post procedure.

• 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: 9871793
• Report Number: 2134265-2020-03743
• Device Sequence Number: 2952436
• Product Code: MAF
• UDI-Device Identifier: 08714729204046
• UDI-Public: 08714729204046
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 03/24/2020

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: 03/26/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023550585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM X 4CM CONQUEST BALLOON
• Outcome Attributed to Adverse Event: Required Intervention