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

Model Number	M001711300
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the moderately tortuous and non-calcified vessel in the biliary tract.During the procedure, it was difficult to push the stent, and the plastic skin of the stent was fractured.Consequently, the stent could not be deployed through the advancer.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the moderately tortuous and non-calcified vessel in the biliary tract.During the procedure, it was difficult to push the stent, and the plastic skin of the stent was fractured.Consequently, the stent could not be deployed through the advancer.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6 - device codes: updated.Device evaluated by mfr: the device was returned for evaluation.The outer sheath was noted to be damaged on several locations along the length of the device.The outer sheath was also noted to be separated approximately 10mm distal from the distal end of the valve body.The markerband was also noted to be damaged.The device was returned with the stent sheathed on the device.The investigator was unable to deploy the stent due to the damage noted to the outer sheath.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified with the device.No other issues were identified with the device.
Additional Manufacturer Narrative
A1 - patient identifier: omq h6 - device codes: updated g4 - premarket / 510(k): k152842, k152853, k992510, k993232 device evaluated by mfr: the device was returned for evaluation.The outer sheath was noted to be damaged on several locations along the length of the device.The outer sheath was also noted to be separated approximately 10mm distal from the distal end of the valve body.The markerband was also noted to be damaged.The device was returned with the stent sheathed on the device.The investigator was unable to deploy the stent due to the damage noted to the outer sheath.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified with the device.No other issues were identified with the device.
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the moderately tortuous and non-calcified vessel in the biliary tract.During the procedure, it was difficult to push the stent, and the plastic skin of the stent was fractured.Consequently, the stent could not be deployed through the advancer.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22556037
• Report Number: 2124215-2025-46724
• Device Sequence Number: 13153291
• Product Code: FGE
• UDI-Device Identifier: 08714729406419
• UDI-Public: (01)08714729406419(17)260118(10)33242444
• 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): 10/27/2025

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: 01/18/2026
• Device Model Number: M001711300
• Device Catalogue Number: M001711300
• Device Lot Number: 0033242444
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/28/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 55 KG