MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT? RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	M001711280
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the stent prematurely deployed.The patient had biliary stenosis and underwent balloon dilatation with stent implantation.An 8x60x75 mm / 6f wallstent reduced profile self-expanding stent was selected for the treatment.During the procedure, a 6f puncture sheath and a 0.035 x 260 cm guidewire were used to cross the lesion.However, the stent could not cross smoothly through the y-valve and was accidentally deployed.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the stent prematurely deployed.The patient had biliary stenosis and underwent balloon dilatation with stent implantation.An 8x60x75 mm / 6f wallstent reduced profile self-expanding stent was selected for the treatment.During the procedure, a 6f puncture sheath and a 0.035 x 260 cm guidewire were used to cross the lesion.However, the stent could not cross smoothly through the y-valve and was accidentally deployed.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.It was further reported that the stent was 80% deployed.The small part tail end of the stent was outside the sheath.The physician pulled it out from the sheath.
Event or Problem Description
It was reported that the stent prematurely deployed.The patient had biliary stenosis and underwent balloon dilatation with stent implantation.An 8 x 60 x 75 mm/6f wallstent reduced profile self-expanding stent was selected for the treatment.During the procedure, a 6f puncture sheath and a 0.035 x 260 cm guidewire were used to cross the lesion.However, the stent could not cross smoothly through the y-valve and was accidentally deployed.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.It was further reported that the stent was 80% deployed.The small part tail end of the stent was outside the sheath.The physician pulled it out from the sheath.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for analysis.As per the ifu this device is compatible with a 6fr sheath.The investigator successfully advanced the device through a 6fr without issue.The sheath used by the customer was not returned for analysis.The device was returned with the stent already deployed from the delivery system.No issues noted with the deployed stent.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified multiple outer sheath kinks along the length of the device.No other issues were identified with the device.

• Brand Name: WALLSTENT? RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 21987867
• Report Number: 2124215-2025-27260
• Device Sequence Number: 19899333
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: (01)08714729406396(17)251210(10)33027843
• 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,Followup,Followup
• Report Date (Section B): 07/02/2025

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: 12/10/2025
• Device Model Number: M001711280
• Device Catalogue Number: M001711280
• Device Lot Number: 0033027843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/11/2025; 06/06/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 65 KG