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

Model Number	H74912044169070
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that stent migration occurred which required an additional stent.A 16x90x75 cm venous wallstent was advanced for treatment.During deployment, the stent appeared to stick to the delivery system, resulting in slight migration.A second venous wallstent was selected for use.During deployment, the stent was found to be sticking to the delivery system shaft, causing a delay in fully coming off and expanding.The procedure was completed with these devices.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that stent migration occurred which required an additional stent.A 16x90x75 cm venous wallstent was advanced for treatment.During deployment, the stent appeared to stick to the delivery system, resulting in slight migration.A second venous wallstent was selected for use.During deployment, the stent was found to be sticking to the delivery system shaft, causing a delay in fully coming off and expanding.The procedure was completed with these devices.No patient complications were reported as a result of this event.It was further reported that the target lesion was located in a non-tortuous, non-calcified vessel, and that no resistance was encountered during the procedure.All steps were noted to have proceeded normally up to the proximal end of the stent.It was reported that all of the stents had been deployed except for the proximal end located between the two marker bands.Deployment of each stent was completed, within approximately 1-2 seconds.No additional maneuvers were required during deployment other than a brief wait before the delivery system was moved.Following release, the procedure was reported to have proceeded normally, and the delivery system was removed without difficulty.No issues were observed with respect to stent expansion or apposition to the vessel wall.However, a slight migration of the first stent was observed, estimated at approximately 0.5 cm.No migration of the second stent was noted, as positioning was closely monitored following the movement of the first stent.The second stent was reported to have possibly been implanted for additional support, although confirmation was not provided; implantation of two stents in this anatomical location was noted to be not unusual.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the venous wallstent device confirmed that the event of stent difficult to deploy and stent migration are known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'cause not established'.
Event or Problem Description
It was reported that stent migration occurred which required an additional stent.A 16 x 90 x 75 cm venous wallstent was advanced for treatment.During deployment, the stent appeared to stick to the delivery system, resulting in slight migration.A second venous wallstent was selected for use.During deployment, the stent was found to be sticking to the delivery system shaft, causing a delay in fully coming off and expanding.The procedure was completed with these devices.No patient complications were reported as a result of this event.It was further reported that the target lesion was located in a non-tortuous, non-calcified vessel, and that no resistance was encountered during the procedure.All steps were noted to have proceeded normally up to the proximal end of the stent.It was reported that all of the stents had been deployed except for the proximal end located between the two marker bands.Deployment of each stent was completed, within approximately 1-2 seconds.No additional maneuvers were required during deployment other than a brief wait before the delivery system was moved.Following release, the procedure was reported to have proceeded normally, and the delivery system was removed without difficulty.No issues were observed with respect to stent expansion or apposition to the vessel wall.However, a slight migration of the first stent was observed, estimated at approximately 0.5 cm.No migration of the second stent was noted, as positioning was closely monitored following the movement of the first stent.The second stent was reported to have possibly been implanted for additional support, although confirmation was not provided; implantation of two stents in this anatomical location was noted to be not unusual.

• 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: 23962247
• Report Number: 2124215-2026-00410
• Device Sequence Number: 13074035
• Product Code: QAN
• UDI-Device Identifier: 08714729979586
• UDI-Public: (01)08714729979586(17)271014(10)37694393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74912044169070
• Device Catalogue Number: H74912044169070
• Device Lot Number: 0037694393
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 03/03/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/04/2026; 03/30/2026
• Date Device Manufactured: 10/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown