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

Model Number	26280
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name:(b)(6).
Event or Problem Description
It was reported that stent damage occurred.The patient had pulmonary malignancy and superior vena cava compression.A 12mm x 90mm wallstent endoprosthesis stent self expanding was selected for use in the superior vena cava.During the procedure, digital subtraction angiography (dsa) showed that the stent had kink marks, which were confirmed after the stent was removed from the body.The procedure was completed with a different device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Event or Problem Description
It was reported that stent damage occurred.The patient had pulmonary malignancy and superior vena cava compression.A 12mm x 90mm wallstent endoprosthesis stent self expanding was selected for use in the superior vena cava.During the procedure, digital subtraction angiography (dsa) showed that the stent had kink marks, which were confirmed after the stent was removed from the body.The procedure was completed with a different device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1, initial reporter phone number: (b)(6).Device eval by manufacturer: the device was returned for evaluation.It was received sheathed, with the stent fully deployed from the delivery system.The stent was observed to be damaged.Visual and tactile inspection revealed no abnormalities at the distal tip of the device.However, an outer sheath kink was identified approximately 85 mm proximal to the distal tip.

• 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: 23548017
• Report Number: 2124215-2025-81168
• Device Sequence Number: 21234752
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: (01)08714729203971(17)260802(10)34558278
• 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): 12/11/2025

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: 08/02/2026
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0034558278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG