MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965403330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k152842, k980163, p980033.Device evaluated by mfr: the wallstent uni was returned for analysis.The device was returned with the stent already deployed from the delivery system.The deployed stent was not returned with the device.A visual examination identified no damage to the stent holder.The stent cup was noted to be damaged.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination of the shaft identified no issues.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 02dec2025.It was reported that the stent failed to deploy.The stenosed target lesion was located in the iliac vein.A 75cm wallstent-uni endoprosthesis self-expanding was selected for use.During the procedure, the stent could not be deployed normally.The procedure was completed with another of same device.There were no patient complications as a result of this event.However, device analysis revealed that the stent already deployed from the delivery system and the stent cup was noted to be damaged.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 23868078
• Report Number: 2124215-2025-92381
• Device Sequence Number: 4451478
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: (01)08714729204053(17)260807(10)34586099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 08/07/2026
• Device Model Number: H965403330
• Device Catalogue Number: H965403330
• Device Lot Number: 0034586099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 67 KG