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

Model Number	26280
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6) good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reporter that the stent failed to deploy resulting in procedure cancellation.The target lesion was located in the lower extremity veins.A 75cm wallstent uni was selected for use.During the procedure, the stent was unable to be deployed properly despite multiple attempts.The device was removed completely and intact from the patient's body and the procedure was concluded.There were no patient complications as a result of this event.The procedure was cancelled as a result of the device malfunction.
Additional Manufacturer Narrative
H6: evaluation conclusion codes: updated.(b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reporter that the stent failed to deploy resulting in procedure cancellation.The target lesion was located in the lower extremity veins.A 75cm wallstent uni was selected for use.During the procedure, the stent was unable to be deployed properly despite multiple attempts.The device was removed completely and intact from the patient's body and the procedure was concluded.There were no patient complications as a result of this event.The procedure was cancelled as a result of the device malfunction.

• 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: 23864530
• Report Number: 2124215-2025-92286
• Device Sequence Number: 9409114
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: (01)08714729204015(17)260606(10)34180955
• 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,Followup
• Report Date (Section B): 02/05/2026

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: 06/06/2026
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0034180955
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 06/06/2024
• 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
• Patient Age: 75 YR
• Patient Sex: Male