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

Model Number	26280
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed.The target lesion was located in the iliac vein.A 16x60/9fr uni plus 75cm wallstent uni stent self-expanding was selected for use.During the procedure, resistance was encountered while advancing the stent, and advancement was not smooth.After reaching the lesion location, the shaft was pulled to deploy the stent; however, the stent did not respond.Resistance occurred when approximately one third of the stent had been deployed.The stent was withdrawn along the guidewire, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).

• 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: 24210405
• Report Number: 2124215-2026-05244
• Device Sequence Number: 5420105
• Product Code: MAF
• UDI-Device Identifier: 08714729204046
• UDI-Public: (01)08714729204046(17)251212(10)33045282
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0033045282
• 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: 01/03/2026
• Initial Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 12/13/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 84 KG