MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT? BILIARY; PROSTHESIS, ESOPHAGEAL

Model Number	H965430500
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted in the bile duct to treat a stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device could not be deployed.The stent remained fully covered by the outer sheath upon removal, and no partial deployment was observed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition was stable at the conclusion of the procedure.Note: it was reported that the shipping mandrel was manually removed prior to advancing the guidewire through the device.Per the ifu, "by inserting the trailing end of the guidewire, the shipping mandrel will be pushed out.Do not remove the shipping mandrel before loading the guidewire." note: this event has been deemed a reportable event based on the investigation finding of inner sheath detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation findings of inner sheath detached.Block h11: a wallstent biliary uncovered stent and its delivery system were received for analysis.The stent was fully covered and undeployed upon receipt.Visual inspection found the stainless-steel shaft detached, the inner sheath broken, and the outer sheath kinked.Media analysis on a provided photograph showed the inner sheath kinked as well.No additional problems were identified with the stent or delivery system.Product analysis could not confirm the reported event of stent failure to deploy as the stent was returned fully covered and undeployed and the delivery system was returned in a condition in which functional deployment testing was unable to be performed.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Taking all available information into consideration, the investigation concluded that the most probable cause is cause not established.

• Brand Name: WALLSTENT? BILIARY
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22560345
• Report Number: 3005099803-2025-03500
• Device Sequence Number: 9699840
• Product Code: MUM
• UDI-Device Identifier: 08714729204671
• UDI-Public: (01)08714729204671(17)251207(10)33014442
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K982184
• 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
• Report Date (Section B): 07/21/2025

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: 12/07/2025
• Device Model Number: H965430500
• Device Catalogue Number: H965430500
• Device Lot Number: 0033014442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 63 KG