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

Model Number	26265
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device was returned to the manufacturer for analysis.A visual examination of the returned device found the stent fully deployed from the delivery system.Stent damage and sheath kinking/accordion damage was also noted.No other issues were identified during analysis.
Event or Problem Description
Reportable based on device analysis completed on 19dec2023.It was reported that the stent was difficult to position.The 70% stenosed target lesion was located in the biliary tract.The patient showed space occupying lesion of pancreas, pancreatic cancer, obstructive jaundice, hypertension.Percutaneous biliary stent implantation was performed as they were in a supine position.A 0.035 non-bsc guidewire and 6f long sheath were selected for the procedure and a 8x60x75/ 6f reduced profile wallstent was advanced for implanting.When the stent reached an unrecoverable point, it was stuck and could not deploy.The stent fully reconstrained by sheath, and the guidewire and stent system were removed outside the body.The procedure was completed with a different device.There were complications reported and the patient was in a stable condition.However, returned device analysis revealed the stent fully deployed from the delivery system.Stent damage and sheath kinking/accordion damage was also noted.

• 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: 18521897
• Report Number: 2124215-2023-75937
• Device Sequence Number: 7558510
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 04/05/2025
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0031379084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 68 KG