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

Model Number	M001711290
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was deformed.The 75% stenosed target lesion was located in the moderately toruous and mildly calcified portal vessel.An 8x60x135 wallstent rp self-expanding stent was chosen for the procedure.During the procedure, the stent was advanced to the target lesion site for deployment.However, it was discovered that the stent could not be successfully deployed.Upon retracting the stent and its delivery system, it was observed that the stent had become deformed.The procedure was completed with aother of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
G4.Premarket / 510(k): 2 numbers are available for this field, k992510 and k152842.
Event or Problem Description
It was reported that the stent was deformed.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified portal vessel.An 8x60x135 wallstent rp self-expanding stent was chosen for the procedure.During the procedure, the stent was advanced to the target lesion site for deployment.However, it was discovered that the stent could not be successfully deployed.Upon retracting the stent and its delivery system, it was observed that the stent had become deformed.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
G4.Premarket / 510(k): 2 numbers are available for this field, k992510 and k152842.E1: initial reported facility name: (b)(6).The device was returned for evaluation and was received with the stent fully deployed from the delivery system.Visual and tactile inspection of the device revealed that the stent was severely kinked at its mid-section.No kinks or damage were observed in the sheath portion of the device upon visual and tactile examination.Similarly, no abnormalities were identified in the tip region of the device during the same evaluation.

• 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: 21662291
• Report Number: 2124215-2025-15711
• Device Sequence Number: 12946070
• Product Code: JCT
• UDI-Device Identifier: 08714729406402
• UDI-Public: (01)08714729406402(17)260305(10)33562336
• 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
• Report Date (Section B): 05/08/2025

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: 03/05/2026
• Device Model Number: M001711290
• Device Catalogue Number: M001711290
• Device Lot Number: 0033562336
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG