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

Model Number	26280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that embolization and thrombosis occurred.The patient was admitted for an iliac vein embolism and underwent multiple procedures on (b)(6) 2025, including inferior vena cava angiography, filter implantation, left lower extremity angiography, balloon dilation, and left iliac vein stent placement.A 75cm wallstent uni was selected for used.The procedure revealed left iliac vein stenosis, after balloon dilation, a stent was placed.However, repeated embolization of the inflow tract caused blood stasis and thrombosis.Re-interventional treatment, including thrombectomy, balloon dilation and catherization thrombolysis reduced the thrombosis and restored blood flow.There were no further patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22940301
• Report Number: 2124215-2025-61198
• Device Sequence Number: 15925970
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: (01)08714729203971(17)260425(10)33899748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 04/25/2026
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0033899748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female