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

Model Number	26265
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the bile duct.An 8x80x75/6f reduced profile wallstent was advanced to treat the lesion, however, the stent could not be delivered.After several failed attempts, it was noted that the sheath was folded.The procedure was not completed.No patient complications were reported, and patient's status was stable.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the bile duct.An 8x80x75/6f reduced profile wallstent was advanced to treat the lesion, however, the stent could not be delivered.After several failed attempts, it was noted that the sheath was folded.The procedure was not completed.No patient complications were reported, and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a reduced profile wallstent was received for analysis.A visual and tactile examination identified that there were multiple outer sheath kinks along the length of the device.The device was received with the stent unsheathed on the delivery system.

• 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: 18365814
• Report Number: 2124215-2023-72439
• Device Sequence Number: 8015010
• Product Code: FGE
• UDI-Device Identifier: 08714729406419
• UDI-Public: 08714729406419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152853
• 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): 02/01/2024

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: 10/12/2024
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0030334748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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: Male
• Patient Weight: 59 KG