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

Model Number	H965430500
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted to treat a 6cm bile duct malignant stenosis during a biliary stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the tip was kinked, and the stent was unable to be deployed.The tip was removed together with the delivery system and another wallstent biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted to treat a 6cm bile duct malignant stenosis during a biliary stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the tip was kinked, and the stent was unable to be deployed.The tip was removed together with the delivery system and another wallstent biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a04 captures the reportable event of tip damaged.A wallstent biliary stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found the inner sheath kinked.A functional inspection was performed, the stent was deployed by actuating the delivery system (slide the handle back along the stainless-steel tube) without problems.No other problems were noted with the stent and delivery system.The observed failure of inner sheath kinked was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the observed failure.The reported event of tip damaged/defective cannot be confirmed because there was no objective evidence or descriptive condition to confirm the reported event.Based on the available information, there is not enough information to confirm the reported event of tip damaged/defective; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• Brand Name: WALLSTENT BILIARY
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18484868
• Report Number: 3005099803-2023-07025
• Device Sequence Number: 18400459
• Product Code: JCT
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 10/25/2024
• Device Model Number: H965430500
• Device Catalogue Number: 43050
• Device Lot Number: 0030421845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 68 KG