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

Model Number	H74912044169070
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent difficult to deploy requiring intervention.The 60% stenosed target lesion was located in the mild tortuous and mild calcified vessel.A 16x90x75cm venous wallstent was selected for use.During the procedure, there was a slight hesitation with full release of the stent off the delivery system until the stent was fully released and additional stent was used.The procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent difficult to deploy requiring intervention.The 60% stenosed target lesion was located in the mild tortuous and mild calcified vessel.A 16x90x75cm venous wallstent was selected for use.During the procedure, there was a slight hesitation with full release of the stent off the delivery system until the stent was fully released and additional stent was used.The procedure was completed with this device.There were no patient complications as a result of this event.It was further reported that the stent was not removed and there were two stents used.It was further reported that the target lesion was located in the iliac vein, and the use of the second stent in the procedure was planned.
Additional Manufacturer Narrative
B5: describe event or problem: updated to include the additional information h6 -impact codes: updated from "additional device required" to "no health consequences or impact".Investigation results: media review: media was received in the form of angiographical images.Review of media identified a slight delay in expansion of the stent, which confirms the event.Device technical analysis: a venous wallstent device was returned for analysis.The device was received unsheathed with the stent already deployed from the delivery system.The deployed stent was not returned with the device.No issues noted with the stent holder or the stent cup.No issues noted with the sheath of the device.A visual and tactile examination identified no issues with the tip of the device.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review was completed and confirmed that the event of 5587: stent - 1299: difficult to deploy was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as cause not established based on the inability to assign a most probable cause for stent deployment and delayed expansion issue from the information provided and the inability to carry out analysis of the stent due to it not being returned.It was stated that the additional device was required due to the procedural event experienced by the patient.
Additional Manufacturer Narrative
B5: describe event or problem: updated investigation results: media review: media was received in the form of angiographical images.Review of media identified a slight delay in expansion of the stent, which confirms the event.Device technical analysis: a venous wallstent device was returned for analysis.The device was received unsheathed with the stent already deployed from the delivery system.The deployed stent was not returned with the device.No issues noted with the stent holder or the stent cup.No issues noted with the sheath of the device.A visual and tactile examination identified no issues with the tip of the device.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review was completed and confirmed that the event of 5587: stent - 1299: difficult to deploy was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as cause not established based on the inability to assign a most probable cause for stent deployment and delayed expansion issue from the information provided and the inability to carry out analysis of the stent due to it not being returned.It was stated that the additional device was required due to the procedural event experienced by the patient.
Event or Problem Description
It was reported that stent difficult to deploy requiring intervention.The 60% stenosed target lesion was located in the mild tortuous and mild calcified vessel.A 16x90x75cm venous wallstent was selected for use.During the procedure, there was a slight hesitation with full release of the stent off the delivery system until the stent was fully released and additional stent was used.The procedure was completed with this device.There were no patient complications as a result of this event.It was further reported that the stent was not removed and there were two stents used.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24464135
• Report Number: 2124215-2026-10892
• Device Sequence Number: 21237762
• Product Code: QAN
• UDI-Device Identifier: 08714729979586
• UDI-Public: (01)08714729979586(17)260916(10)34857306
• 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: 2026
• 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): 04/29/2026

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 Expiration Date: 09/16/2026
• Device Model Number: H74912044169070
• Device Catalogue Number: H74912044169070
• Device Lot Number: 0034857306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 02/20/2026; 04/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/18/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown