MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VENOUS WALLSTENT?; STENT, ILIAC VEIN

Model Number	H74912044208070
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 02jul2025.It was reported that the stent unable to advance in anatomy.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified venous artery.After predilation, the stenosis was 40%.A 20x80x75cm venous wallstent self-expanding was selected for use.During the procedure, it was noted that the device was unable to advance in the anatomy.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed damaged distal stent wires.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned with the stent partially deployed on the delivery system.The distal stent wires were noted to be damaged.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile inspection found multiple kinks to the sheath of the device.No other issues were identified during the product analysis.

• Brand Name: VENOUS WALLSTENT?
• Common Device Name: STENT, ILIAC VEIN
• 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: 22615429
• Report Number: 2124215-2025-49212
• Device Sequence Number: 20198252
• Product Code: QAN
• UDI-Device Identifier: 08714729979647
• UDI-Public: (01)08714729979647(17)250810(10)32197598
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: 08/10/2025
• Device Model Number: H74912044208070
• Device Catalogue Number: H74912044208070
• Device Lot Number: 0032197598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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 Sex: Unknown