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

Model Number	H74912044166070
Medical Device Problem Codes	Positioning Failure (1158); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 16x60x75cm venous wallstent self-expanding was selected for use to treat may-thurner syndrome.During stent implantation, it was noted that the distal tip appeared crushed.Additionally, the guidewire was not properly positioned, and it had slightly migrated.The stent was not deployed and was removed, and procedure was completed with another stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received with the stent partially deployed on the delivery system.The investigator successfully deployed the stent with no resistance experienced.A visual examination identified damage to the distal wires of the deployed stent.A visual and tactile examination identified no damage or issues with the tip or delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.A 16x60x75cm venous wallstent self-expanding was selected for use to treat may-thurner syndrome.During stent implantation, it was noted that the distal tip appeared crushed.Additionally, the guidewire was not properly positioned, and it had slightly migrated.The stent was not deployed and was removed, and procedure was completed with another stent.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: 22073917
• Report Number: 2124215-2025-31346
• Device Sequence Number: 21166561
• Product Code: QAN
• UDI-Device Identifier: 08714729979579
• UDI-Public: (01)08714729979579(17)250625(10)31895555
• Combination Product (Y/N): N
• 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): 07/10/2025

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: 06/25/2025
• Device Model Number: H74912044166070
• Device Catalogue Number: H74912044166070
• Device Lot Number: 0031895555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 84 KG