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

Model Number	H74912044208070
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that holes in the catheter occurred.The 80% stenosed target lesion was severely tortuous and severely calcified.A 20x80x75cm venous wallstent was selected for use.During insertion, it was noted that there were holes in the catheter and the middle of the catheter was kinked.The procedure was completed with a 20 x 80 wallstent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6: evaluation conclusion codes: updated from no problem detected to unintended use error caused or contributed to event.
Event or Problem Description
It was reported that holes in the catheter occurred.The 80% stenosed target lesion was severely tortuous and severely calcified.A 20x80x75cm venous wallstent was selected for use.During insertion, it was noted that there were holes in the catheter and the middle of the catheter was kinked.The procedure was completed with a 20 x 80 wallstent.There were no patient complications as a result of this event.

• 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: 23063356
• Report Number: 2124215-2025-64252
• Device Sequence Number: 15868698
• Product Code: QAN
• UDI-Device Identifier: 08714729979647
• UDI-Public: (01)08714729979647(17)261112(10)35266053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Model Number: H74912044208070
• Device Catalogue Number: H74912044208070
• Device Lot Number: 0035266053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 11/12/2024
• 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 Sex: Unknown