MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT Endoprosthesis; catheter, biliary, diagnostic

Model Number	26280
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break, removal difficulty, and partial deployment occurred.The target lesion was located in the lower extremity veins.A 12x90/8fr uni plus halo 75cm wallstent uni was selected for use.During the procedure, the stent was delivered into the body and deployed after reaching the lesion site.During the deployment, the delivery shaft was fractured, and the tail end could not be pulled.After many rotations, the stent could not be pulled.The stent was only deployed at the tip end, and the back part was not deployed.The physician used the adjustable curved sheath to pull out the stent after many attempts.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status post procedure was stable.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25738421
• Report Number: 2124215-2026-36347
• Device Sequence Number: 16067085
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: (01)08714729203971(17)260820(10)34672792
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/17/2026

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: 08/20/2026
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0034672792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 08/20/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 151 LB