MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Express SD Renal/Biliary; stents, drains and dilators for the biliary ducts

Model Number	H74937911614150
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent failure to expand occurred.The target lesion was located in the very tortuous and tight superior mesenteric artery.A 6.0mmx14mmx150cm express sd renal/biliary was selected for use.During the procedure, the stent was not fully expanded in the lesion.The procedure was completed with this device.There were no patient complications as a result of this event.

• Brand Name: Express SD Renal/Biliary
• Common Device Name: stents, drains and dilators for the biliary ducts
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25627571
• Report Number: 2124215-2026-33955
• Device Sequence Number: 10194931
• Product Code: FGE
• UDI-Device Identifier: 08714729484820
• UDI-Public: (01)08714729484820(17)280304(10)35993889
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K162404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/29/2026

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 Model Number: H74937911614150
• Device Catalogue Number: H74937911614150
• Device Lot Number: 0035993889
• 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: 05/31/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male