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

Model Number	26280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent profile problem was encountered.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left iliac vein.A 14x60/9fr uni plus 75cm wallstent endoprosthesis self expanding was advanced for treatment of the patient pressure syndrome.The stent was deployed normally; however, after deploying about two centimeters, the stent ejected itself from the delivery system and the delivery system bounced off and retreated to the sheath orifice of the vessel.It appeared that the stent was not fully opened.Angiography revealed that the anterior portion of the stent was apposed to the vessel wall while the posterior half was not, and a blockage had formed in the lumen causing contrast retention.After post-dilatation, radiography showed improvement in flow rate and stagnation.The procedure was completed successfully.The patient condition following the procedure was stable.There were no patient complications as result of this event.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1-initial reporter address 1: no.(b)(6).Device evaluated by mfr.: the wallstent uni was returned for analysis.The device was received with the stent already deployed from the delivery system.A visual examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip and shaft of the device.
Event or Problem Description
It was reported that stent profile problem was encountered.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left iliac vein.A 14x60/9fr uni plus 75cm wallstent endoprosthesis self expanding was advanced for treatment of the patient pressure syndrome.The stent was deployed normally; however, after deploying about two centimeters, the stent ejected itself from the delivery system and the delivery system bounced off and retreated to the sheath orifice of the vessel.It appeared that the stent was not fully opened.Angiography revealed that the anterior portion of the stent was apposed to the vessel wall while the posterior half was not, and a blockage had formed in the lumen causing contrast retention.After post-dilatation, radiography showed improvement in flow rate and stagnation.The procedure was completed successfully.The patient condition following the procedure was stable.There were no patient complications as 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: 21742873
• Report Number: 2124215-2025-20037
• Device Sequence Number: 4109341
• Product Code: MAF
• UDI-Device Identifier: 08714729204008
• UDI-Public: (01)08714729204008(17)260121(10)33260641
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/21/2025

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: 0033260641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG