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

Model Number	26280
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: this wallstent endoprosthesis was received for analysis.Visual examination identified that the stent was partially deployed and damaged.Further visual and tactile examination identified no issues with the tip or shaft of the device.
Event or Problem Description
Reportable upon analysis completed on (b)(6)2025.The 90% stenosed target lesion was located in the severely tortuous and severely calcified iliac artery.A 14x90/9 wallstent endoprosthesis was selected for use.During the procedure, the device was inserted into the patient; however, the product was unable to traverse the lesion.As a result, the physician subsequently withdrew the product.The procedure was completed with another of the same device with a different lot number.There were no patient complications as a result of this event.

• 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: 21753526
• Report Number: 2124215-2025-18393
• Device Sequence Number: 8220247
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: (01)08714729204015(17)260121(10)33260645
• 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): 04/02/2025

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: 01/21/2026
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0033260645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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: 72 YR
• Patient Sex: Female